Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-25 @ 4:10 PM
Study NCT ID:
NCT04854057
Status:
TERMINATED
Last Update Posted:
2024-01-10
First Post:
2021-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pairing Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Promote Arm Use After Cervical SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'randy.trumbower@mgh.harvard.edu', 'phone': '6179526822', 'title': 'Dr. Randy Trumbower', 'organization': 'Spaulding Rehabilitation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '199 days', 'eventGroups': [{'id': 'EG000', 'title': 'Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 1', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round 2', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round1', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First Round2', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pressure ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Upper Extremity Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).'}, {'id': 'OG001', 'title': 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).'}], 'classes': [{'title': 'Round 1 Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-2'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '13'}]}]}, {'title': 'Round 1Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '15'}]}]}, {'title': 'Round 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '6'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '17'}]}]}, {'title': 'Round 1 Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '8'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '4'}]}]}, {'title': 'Round 2 Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '-1'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '17'}]}]}, {'title': 'Round 2 Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '18'}]}]}, {'title': 'Round 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-2'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '17'}]}]}, {'title': 'Round 2 Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '16'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8)', 'description': 'Change compared to baseline in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: -188 to 188. Higher values represent a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject from SHAM+TESS First group dropped out after round 2 day 5.'}, {'type': 'PRIMARY', 'title': 'Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).'}, {'id': 'OG001', 'title': 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).'}], 'classes': [{'title': 'Round 1 Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-.47', 'groupId': 'OG000', 'lowerLimit': '-.47', 'upperLimit': '-.47'}, {'value': '1.65', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3.30'}]}]}, {'title': 'Round 1 Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-.63', 'groupId': 'OG000', 'lowerLimit': '-.63', 'upperLimit': '-.63'}, {'value': '1.63', 'groupId': 'OG001', 'lowerLimit': '-0.33', 'upperLimit': '3.60'}]}]}, {'title': 'Round 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-.33', 'groupId': 'OG000', 'lowerLimit': '-.33', 'upperLimit': '-.33'}, {'value': '2.63', 'groupId': 'OG001', 'lowerLimit': '-0.17', 'upperLimit': '5.43'}]}]}, {'title': 'Round 1 Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.10', 'groupId': 'OG000', 'lowerLimit': '.10', 'upperLimit': '.10'}, {'value': '3.13', 'groupId': 'OG001', 'lowerLimit': '0.40', 'upperLimit': '5.87'}]}]}, {'title': 'Round 2 Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-.13', 'groupId': 'OG000', 'lowerLimit': '-.13', 'upperLimit': '-.13'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.37'}]}]}, {'title': 'Round 2 Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.63', 'groupId': 'OG000', 'lowerLimit': '.63', 'upperLimit': '.63'}, {'value': '1.53', 'groupId': 'OG001', 'lowerLimit': '1.53', 'upperLimit': '1.53'}]}]}, {'title': 'Round 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.47', 'groupId': 'OG000', 'lowerLimit': '.47', 'upperLimit': '.47'}, {'value': '-0.43', 'groupId': 'OG001', 'lowerLimit': '-0.43', 'upperLimit': '-0.43'}]}]}, {'title': 'Round 2 Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.50', 'groupId': 'OG000', 'lowerLimit': '.50', 'upperLimit': '.50'}, {'value': '-0.10', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '-0.10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once each intervention week (days 5, 10, and 15), and once at followup (week 8)', 'description': 'Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.', 'unitOfMeasure': 'kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject from SHAM+TESS First group dropped out after round 2 day 5.'}, {'type': 'PRIMARY', 'title': 'Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).'}, {'id': 'OG001', 'title': 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).'}], 'classes': [{'title': 'Round 1 Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.97'}]}]}, {'title': 'Round 1 Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.60'}]}]}, {'title': 'Round 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.17', 'groupId': 'OG000', 'lowerLimit': '.17', 'upperLimit': '.17'}, {'value': '0.77', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.53'}]}]}, {'title': 'Round 1 Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2.35', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '4.70'}]}]}, {'title': 'Round 2 Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '-2.28', 'groupId': 'OG001', 'lowerLimit': '-4.57', 'upperLimit': '0.00'}]}]}, {'title': 'Round 2 Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.27', 'groupId': 'OG001', 'lowerLimit': '0.27', 'upperLimit': '0.27'}]}]}, {'title': 'Round 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.17', 'groupId': 'OG000', 'lowerLimit': '.17', 'upperLimit': '.17'}, {'value': '2.40', 'groupId': 'OG001', 'lowerLimit': '2.40', 'upperLimit': '2.40'}]}]}, {'title': 'Round 2 Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '1.37', 'groupId': 'OG001', 'lowerLimit': '1.37', 'upperLimit': '1.37'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once each intervention week (days 5, 10, and 15), and once at followup (week 8)', 'description': 'Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.', 'unitOfMeasure': 'kg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject from SHAM+TESS First group dropped out after round 2 day 5.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).'}, {'id': 'FG001', 'title': 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days):Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).'}, {'id': 'BG001', 'title': 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nRound 1 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 First Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 Second Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 2 Third Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Upper Extremity Function', 'classes': [{'title': 'Round 1', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '39'}, {'value': '91', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '155'}, {'value': '74.7', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '155'}]}]}, {'title': 'Round 2', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '47'}, {'value': '90.5', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '159'}, {'value': '76', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '159'}]}]}], 'paramType': 'MEAN', 'description': 'Upper extremity function performance metrics assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: 0 to 188. Higher values represent a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand', 'classes': [{'title': 'Round 1 Baseline', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'BG000', 'lowerLimit': '3.5', 'upperLimit': '3.5'}, {'value': '14.3', 'groupId': 'BG001', 'lowerLimit': '.5', 'upperLimit': '28.1'}, {'value': '10.7', 'groupId': 'BG002', 'lowerLimit': '.5', 'upperLimit': '28.1'}]}]}, {'title': 'Round 2 Baseline', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'BG000', 'lowerLimit': '3.6', 'upperLimit': '3.6'}, {'value': '17.45', 'groupId': 'BG001', 'lowerLimit': '.9', 'upperLimit': '34.0'}, {'value': '12.8', 'groupId': 'BG002', 'lowerLimit': '.9', 'upperLimit': '34.0'}]}]}], 'paramType': 'MEAN', 'description': 'Upper extremity strength assessed using dynamometers to measure grip forces.', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Upper Extremity Strength - Cylindrical Grip - More Impaired Hand', 'classes': [{'title': 'Round 1 Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '12.7', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '25.4'}, {'value': '8.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '25.4'}]}]}, {'title': 'Round 2 Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '15.1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '30.1'}, {'value': '10.0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '30.1'}]}]}], 'paramType': 'MEAN', 'description': 'Upper extremity strength assessed using dynamometers to measure grip forces.', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-29', 'size': 643037, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-18T16:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'No funding or personnel for project. We are unable to meet the recruitment goals for this pilot study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2021-04-14', 'resultsFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-09', 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Upper Extremity Function', 'timeFrame': 'Once each intervention week (days 5, 10, and 15), and once at follow-up (week 8)', 'description': 'Change compared to baseline in upper extremity function performance metrics after treatment assessed using the Graded Redefined Assessment of Strength, Sensation and Prehension test (GRASSP v2). Range: -188 to 188. Higher values represent a better outcome.'}, {'measure': 'Change in Upper Extremity Strength - Cylindrical Grip - Less Impaired Hand', 'timeFrame': 'Once each intervention week (days 5, 10, and 15), and once at followup (week 8)', 'description': 'Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.'}, {'measure': 'Change in Upper Extremity Strength - Cylindrical Grip - More Impaired Hand', 'timeFrame': 'Once each intervention week (days 5, 10, and 15), and once at followup (week 8)', 'description': 'Change in upper extremity strength compared to baseline assessed using dynamometers to measure grip forces.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hypoxia', 'spinal cord injury', 'rehabilitation', 'function', 'low oxygen'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '28972191', 'type': 'BACKGROUND', 'citation': 'Trumbower RD, Hayes HB, Mitchell GS, Wolf SL, Stahl VA. Effects of acute intermittent hypoxia on hand use after spinal cord trauma: A preliminary study. Neurology. 2017 Oct 31;89(18):1904-1907. doi: 10.1212/WNL.0000000000004596. Epub 2017 Sep 29.'}, {'pmid': '29877852', 'type': 'BACKGROUND', 'citation': 'Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.'}, {'pmid': '24244094', 'type': 'BACKGROUND', 'citation': 'Hoffman L, Field-Fote E. Effects of practice combined with somatosensory or motor stimulation on hand function in persons with spinal cord injury. Top Spinal Cord Inj Rehabil. 2013 Fall;19(4):288-99. doi: 10.1310/sci1904-288.'}, {'pmid': '29649928', 'type': 'BACKGROUND', 'citation': 'Gad P, Lee S, Terrafranca N, Zhong H, Turner A, Gerasimenko Y, Edgerton VR. Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. J Neurotrauma. 2018 Sep 15;35(18):2145-2158. doi: 10.1089/neu.2017.5461.'}], 'seeAlsoLinks': [{'url': 'https://www.inspire-lab.org/', 'label': 'INSPIRE Lab - dedicated to inspire persons with paralysis to move again'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the efficacy of mild breathing bouts of low oxygen (intermittent hypoxia) combined with transcutaneous electrical spinal cord stimulation on restoring hand function in persons with chronic incomplete spinal cord injury.', 'detailedDescription': 'The goal of this study is to determine the effectiveness of repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) combined with non-invasive transcutaneous electrical spinal cord stimulation (TESS) on restoring hand function in persons with chronic incomplete SCI.\n\nThe fundamental hypothesis guiding this proposal is that daily AIH+TESS engage excitatory and inhibitory pathways, which converge on a common plasticity-promoting cascade that induces greater recovery of hand function than either one alone.\n\nBoth treatments appear to enhance motor function in persons with cervical SCI. Despite their independent effects on promoting functional benefits, it is not yet know if they may promote greater functional benefits when combined. To be effective as a long-term rehabilitation strategy, it is essential to determine the efficacy of combined protocols of recurring AIH+TESS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years old\n* medically stable with medical clearance from physician to participate\n* SCI at or below C3 and at or above C7\n* non-progressive etiology of spinal injury\n* American Spinal Injury Association Impairment Scale (AIS) C-D at initial screen\n* at least 1 year post-injury (chronic)\n* difficulty independently performing hand functions in activities of daily living\n\nExclusion Criteria:\n\n* dependence on ventilation support\n* implanted stimulator (e.g. diaphragm pacing by phrenic nerve stimulation, vagus nerve stimulator, pacemaker, cochlear implant, epidural stimulator, baclofen pump, etc.)\n* spinal cord injury related complications including unhealed pressure sore, severe neuropathic or chronic pain syndrome, history of frequent autonomic dysreflexia, infection (e.g. urinary tract), cardiovascular disease (e.g. deep vein thrombosis), pulmonary disease, heterotopic ossification in the upper extremities, severe osteoporosis, unhealed fracture, contracture of the upper extremity joints\n* received botulinum toxin injections in upper extremity muscles in the prior 6 months\n* history of tendon or nerve transfer surgery in the upper extremity\n* history of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) or peripheral nerve injury in the upper extremity\n* history of concomitant diseases that would prevent full participation in intensive exercise therapy, such as uncontrolled hypertension, rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), pulmonary disease, active cancer, chronic contagious disease, etc.\n* anticoagulation medication\n* pregnancy\n* history of allergic reaction or any skin reaction to use of adhesive electrodes'}, 'identificationModule': {'nctId': 'NCT04854057', 'briefTitle': 'Pairing Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Promote Arm Use After Cervical SCI', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Combinatorial Treatment of Acute Intermittent Hypoxia and Transcutaneous Electrical Spinal Cord Stimulation to Improve Hand Function in People With Cervical Spinal Cord Injury', 'orgStudyIdInfo': {'id': '2020P003328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 1 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).\n\nWashout (1 month)\n\nRound 2 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM.\n\nRound 2 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH.', 'interventionNames': ['Other: AIH - Intermittent Hypoxia - hypoxia air mixture', 'Other: SHAM - Intermittent Room Air - room air mixture', 'Device: TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice']}, {'type': 'EXPERIMENTAL', 'label': 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'description': 'Round 1 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 1 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM.\n\nRound 1 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH.\n\nWashout (1 month)\n\nRound 2 1st Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice alone for 45 mins.\n\nRound 2 2nd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after AIH (15x 1.5 mins bouts of 10% oxygen with 1 min intervals of room air).\n\nRound 2 3rd Intervention (4 days): Participants receive 4 consecutive days of TESS during functional task practice for 45 mins after SHAM (15x 1.5 mins bouts of 21% oxygen with 1 min intervals of room air).', 'interventionNames': ['Other: AIH - Intermittent Hypoxia - hypoxia air mixture', 'Other: SHAM - Intermittent Room Air - room air mixture', 'Device: TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice']}], 'interventions': [{'name': 'AIH - Intermittent Hypoxia - hypoxia air mixture', 'type': 'OTHER', 'description': 'Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.10±0.02 (hypoxia). Participants will receive treatment 4 times per week.', 'armGroupLabels': ['Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First']}, {'name': 'SHAM - Intermittent Room Air - room air mixture', 'type': 'OTHER', 'description': 'Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.21±0.02 (normoxia). Participants will receive treatment 4 times per week.', 'armGroupLabels': ['Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First']}, {'name': 'TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice', 'type': 'DEVICE', 'description': 'Participants will receive transcutaneous electrical stimulation to the cervical spinal cord using the TESCoN device developed by SpineX, Inc. Training will consist of progressive functional task practice for upper extremity motor training. A total of 24 treatment sessions, which will last 45 minutes per session, will be completed in 3 weeks (4 days/week) per crossover arm.', 'armGroupLabels': ['Intermittent Hypoxia (AIH) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First', 'Intermittent Room Air (SHAM) + Transcutaneous Electrical Spinal Cord Stimulation (TESS) First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Randy Trumbower, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Randy Trumbower, PT, PhD', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}