Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-31 @ 5:54 AM
Study NCT ID:
NCT03184792
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2017-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'finanici@uw.edu', 'phone': '2067872692', 'title': 'Dr. Fatma Inanici', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 years', 'description': 'The intervention carries a low risk of mild adverse events. For that reason, serious adverse events were not expected.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: "Physical therapy only"', 'description': 'Physical therapy: Physical therapy to improve arm and hand functions', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm B: "Transcutaneous spinal stimulation & Physical therapy"', 'description': 'Transcutaneous spinal stimulation: Non-invasive electrical stimulation of the cervical spinal cord over the skin combined with Physical therapy to improve arm and hand functions.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Therapy only', 'description': 'All participants, when they receive the "physical therapy only" intervention arm.'}, {'id': 'OG001', 'title': 'Transcutaneous Spinal Cord Stimulation combined with Physical Therapy', 'description': 'All participants, when they receive Transcutaneous Spinal Cord Stimulation combined with Physical Therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.5', 'ciLowerLimit': '6.6', 'ciUpperLimit': '12.4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.4', 'ciLowerLimit': '3.7', 'ciUpperLimit': '17.0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function: strength (manual muscle strength testing), sensibility (Semmes-Weinstein monofilament sensation test), and prehension (ability and performance to generate various grasp and pinch movements using a water bottle, jar, key, pegs, coins, and nuts).\n\nThe total score is calculated as the sum of the subscale scores. The minimum score is zero, and the maximum score is 232 points. Higher Scores mean a better outcome.\n\nScore change before and after each intervention is calculated.', 'unitOfMeasure': 'score change before and after', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Therapy only', 'description': 'All participants, when they receive the "physical therapy only" intervention arm.'}, {'id': 'OG001', 'title': 'Transcutaneous Spinal Cord Stimulation combined with Physical Therapy', 'description': 'All participants, when they receive the "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy" intervention arm.'}], 'classes': [{'title': 'Subscore 1: Myotomal-based Motor Examination', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Subscale 2: The Dermatomal-based Sensory Examination', 'categories': [{'measurements': [{'value': '1.6', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination Subscale 1: Myotomal-based Motor Examination - measures the motor function of the extremities. The minimum score is zero, and the maximum score is 100. Higher scores represent better outcomes.\n\nSubscale 2: The Dermatomal-based Sensory Examination - measures the sensory function of the whole body dermatomes. The minimum score is zero, and the maximum score is 224. Higher scores represent better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Grip and Pinch Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical therapy only', 'description': 'All participants, when they receive the "physical therapy only" intervention arm.'}, {'id': 'OG001', 'title': 'Transcutaneous Spinal Cord Stimulation combined with Physical Therapy', 'description': 'All participants, when they receive the "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy" intervention arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '2', 'groupId': 'OG000'}, {'value': '12', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Hand strength measurement by dynamometry.\n\nThe change in strength (improvement) before and at the end of each intervention arm is calculated.', 'unitOfMeasure': 'kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Numeric Pain Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'physical therapy only', 'description': 'All participants, when they receive the "physical therapy only" intervention arm.'}, {'id': 'OG001', 'title': 'Transcutaneous Spinal Cord Stimulation combined with Physical Therapy', 'description': 'All participants, when they receive the "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy" intervention arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Patient reported pain rating on a 0 to 10 scale. The mean score change (improvement) before and at the end of each intervention arm is calculated.\n\nZero means no pain, 10 means the worst pain one can imagine. Higher scores mean worse pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Penn Spasm Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical therapy only', 'description': 'All participants, while they receive "Physical Therapy only" intervention arm.'}, {'id': 'OG001', 'title': 'Transcutaneous Spinal Cord Stimulation combined with Physical Therapy', 'description': 'All participants, while they receive "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy" intervention arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spinal Cord Independence Measure (SCIM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical therapy only', 'description': 'All participants, when they receive "Physical Therapy Only" intervention arm.'}, {'id': 'OG001', 'title': 'ranscutaneous Spinal Cord Stimulation combined with Physical Therapy', 'description': 'All participants, when they receive the "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy" intervention arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Clinician-administered disability questionnaire for patients with spinal cord lesions.\n\nThe total SCIM scores range from 0 to 100. Higher scores mean better outcomes. Score change (improvement) relative to baseline or previous intervention arm is calculated.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'World Health Organization-Quality of Life - (WHO-QoL-BREF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical therapy only', 'description': 'All participants, when they receive the "Physical Therapy Only" intervention arm.'}, {'id': 'OG001', 'title': 'Transcutaneous Spinal Cord Stimulation combined with Physical Therapy', 'description': 'All participants, when they receive the "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy" intervention arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Patient-reported quality of life scale. A higher score indicates a higher quality of life. Score change (improvement) relative to baseline or prior intervention arm is calculated.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 (Cross-over Intervention arm sequence: AB)', 'description': 'The sequence of cross-arm intervention for Group 1 will be as follows: "Physical therapy only (Arm A) first" and "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) second."'}, {'id': 'FG001', 'title': 'Group 2 (Cross-over Intervention arm sequence: BA)', 'description': 'The sequence of cross-arm intervention for Group 2 will be as follows: "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) first" and "Physical therapy only (Arm A) second."'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Group 1 (Cross-over intervention arm sequence AB): 7 participants received "Physical therapy only (Arm A)" as the FIRST intervention, and "Transcutaneous spinal stimulation \\& Physical therapy (Arm B)" as the SECOND intervention.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'Group 2 (Cross-over intervention arm sequence BA): 8 participants enrolled to receive "Transcutaneous spinal stimulation \\& Physical therapy (Arm B)" as the FIRST intervention, then Physical therapy only (Arm A)" as the SECOND intervention.', 'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'In Group 1 (Cross-over intervention sequence is AB), 5 participants completed the study.', 'groupId': 'FG000', 'numSubjects': '5'}, {'comment': 'In Group 2 (Cross-over intervention arm sequence is BA), 6 participants completed the study.', 'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'We use advertisement flyers and information sheets that will be clearly displayed in the neurosurgery and rehabilitation outpatient departments at the University of Washington, for all to see. Recruitment began on December 1, 2017, and concluded on December 1, 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator', 'description': 'The sequence of cross-arm intervention for Group 1 will be as follows: "Physical therapy only (Arm A) first" and "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) second."\n\nPhysical Therapy only is the active comparator intervention.'}, {'id': 'BG001', 'title': 'Group 2 (Cross-over Intervention arm sequence: BA) - Experimental', 'description': 'The sequence of cross-arm intervention for Group 2 will be as follows: "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) first" and "Physical therapy only (Arm A) second."\n\nTranscutaneous Spinal Cord Stimulation, combined with physical therapy, is the experimental intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'spread': '14', 'groupId': 'BG000'}, {'value': '60', 'spread': '6', 'groupId': 'BG001'}, {'value': '59', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'International Standards for Neurological Classification of SCI (ISNCSCI)', 'classes': [{'title': 'Subscale 1: Myotomal-based Motor Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.1', 'spread': '21.5', 'groupId': 'BG000'}, {'value': '49.8', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '49.9', 'spread': '17.8', 'groupId': 'BG002'}]}]}, {'title': 'Subscale 2:Dermatomal-based Sensory Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '111.0', 'spread': '43.3', 'groupId': 'BG000'}, {'value': '113.8', 'spread': '36.4', 'groupId': 'BG001'}, {'value': '112.4', 'spread': '35.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'International Standards for Neurological Classification of Spinal Cord Injury\n\nSubscale 1: Myotomal-based Motor Examination - measures the motor function of the extremities. The minimum score is zero, and the maximum score is 100. Higher scores represent better outcomes.\n\nSubscale 2: The Dermatomal-based Sensory Examination - measures the sensory function of the whole body dermatomes. The minimum score is zero, and the maximum score is 224. Higher scores represent better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-22', 'size': 156393, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-21T13:20', 'hasProtocol': True}, {'date': '2022-02-22', 'size': 100012, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-21T13:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will be randomized into two groups:\n\nGroup 1.) Six weeks of "Physical therapy only" (Arm A) as the first intervention and then 6 weeks of "Transcutaneous spinal stimulation \\& Physical therapy" (Arm B) as the second intervention.\n\nGroup 2.) Six weeks of "Transcutaneous spinal stimulation \\& Physical therapy" (Arm B) as the first intervention, and then "Physical therapy only" (Arm A) as the second intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2017-06-07', 'resultsFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-10', 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test)', 'timeFrame': '6 months', 'description': 'GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function: strength (manual muscle strength testing), sensibility (Semmes-Weinstein monofilament sensation test), and prehension (ability and performance to generate various grasp and pinch movements using a water bottle, jar, key, pegs, coins, and nuts).\n\nThe total score is calculated as the sum of the subscale scores. The minimum score is zero, and the maximum score is 232 points. Higher Scores mean a better outcome.\n\nScore change before and after each intervention is calculated.'}], 'secondaryOutcomes': [{'measure': 'International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination', 'timeFrame': '6 months', 'description': 'International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination Subscale 1: Myotomal-based Motor Examination - measures the motor function of the extremities. The minimum score is zero, and the maximum score is 100. Higher scores represent better outcomes.\n\nSubscale 2: The Dermatomal-based Sensory Examination - measures the sensory function of the whole body dermatomes. The minimum score is zero, and the maximum score is 224. Higher scores represent better outcomes.'}, {'measure': 'Grip and Pinch Strength', 'timeFrame': '6 months', 'description': 'Hand strength measurement by dynamometry.\n\nThe change in strength (improvement) before and at the end of each intervention arm is calculated.'}, {'measure': 'Numeric Pain Rating Scale', 'timeFrame': '6 months', 'description': 'Patient reported pain rating on a 0 to 10 scale. The mean score change (improvement) before and at the end of each intervention arm is calculated.\n\nZero means no pain, 10 means the worst pain one can imagine. Higher scores mean worse pain.'}, {'measure': 'Penn Spasm Score', 'timeFrame': '6 months', 'description': 'Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2).'}, {'measure': 'Spinal Cord Independence Measure (SCIM)', 'timeFrame': '6 months', 'description': 'Clinician-administered disability questionnaire for patients with spinal cord lesions.\n\nThe total SCIM scores range from 0 to 100. Higher scores mean better outcomes. Score change (improvement) relative to baseline or previous intervention arm is calculated.'}, {'measure': 'World Health Organization-Quality of Life - (WHO-QoL-BREF)', 'timeFrame': '6 months', 'description': 'Patient-reported quality of life scale. A higher score indicates a higher quality of life. Score change (improvement) relative to baseline or prior intervention arm is calculated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Spinal electrical stimulation'], 'conditions': ['Spinal Cord Injury Cervical', 'Upper Extremity Dysfunction']}, 'descriptionModule': {'briefSummary': 'Stimulation of the spinal cord may induce the growth and reorganization of neural pathways leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical spinal cord stimulation improves motor functions immediately via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated to be effective for improving lower limb motor function in healthy individuals and in patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical electrical stimulation can enhance conscious motor control and functions of hand and arm via neuromodulation of spinal network.\n\nThis study is a prospective efficacy trial of transcutaneous cervical electrical stimulation for improving upper limb function in patients with traumatic or degenerative cervical spinal cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the United States Food and Drug Administration for treatment of spinal cord injury.\n\nThe interventions include either transcutaneous cervical spinal electrical stimulation combined with physical therapy or physical therapy only. The order of the interventions will be randomized for each subject in a delayed cross-over design. Total duration of the study is 6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks follow-up. Both immediate and lasting improvements in hand motor and sensory function via transcutaneous cervical spinal stimulation will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cervical (C7 or higher) spinal cord injury at least 1-year duration\n* Incomplete spinal cord injury (American Spinal Injury Association Impairment Scale (AIS) C or D)\n* Between 21 and 70 years of age\n* Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding)\n* Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities\n* Capable of performing simple cued motor tasks\n* Ability to attend 2 to 5 sessions of weekly physical therapy sessions and testing activities\n* Adequate social support to be able to participate in weekly training and assessment sessions for the duration of 6 months within the study period.\n* Ability to read and speak English\n\nExclusion Criteria:\n\n* Autoimmune etiology of spinal cord dysfunction/injury\n* History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc.\n* Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)\n* Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)\n* Significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.\n* Active cancer\n* Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention\n* Unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with upper extremity rehabilitation or testing activities\n* Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician\n* Pregnancy\n* Tendon or nerve transfer surgery in the upper limbs\n* Botulinum toxin injections in the prior 6 months\n* Dependent on ventilation support\n* Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc).\n* Has depression or anxiety based on Patient Health Questionnaire and General Anxiety Disorder-7 item Questionnaire\n* Diagnosed with syringomyelia\n* Alcohol and/or drug abuse.\n* Cognitive impairment based on Short Portable Mental Status Questionnaire\n* Unable to read and/or comprehend the consent form.\n* Unable to understand the instructions given as part of the study.'}, 'identificationModule': {'nctId': 'NCT03184792', 'acronym': 'ADDRESS', 'briefTitle': 'Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'STUDY00002985'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physical therapy only (Arm A)', 'description': 'Physical therapy that targets the rehabilitation of upper extremity functions', 'interventionNames': ['Other: Physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B)', 'description': 'Application of Transcutaneous cervical electrical stimulation combined with physical therapy that targets the rehabilitation of upper extremity functions', 'interventionNames': ['Device: Transcutaneous spinal stimulation', 'Other: Physical therapy']}], 'interventions': [{'name': 'Transcutaneous spinal stimulation', 'type': 'DEVICE', 'description': 'Non-invasive electrical stimulation of cervical spinal cord over the skin', 'armGroupLabels': ['Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B)']}, {'name': 'Physical therapy', 'type': 'OTHER', 'otherNames': ['Exercise therapy'], 'description': 'Physical therapy to improve arm and hand functions', 'armGroupLabels': ['Physical therapy only (Arm A)', 'Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '981095', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Chet T Moritz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Rehabilitative Medicine', 'investigatorFullName': 'Chet Moritz', 'investigatorAffiliation': 'University of Washington'}}}}