Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-28 @ 6:17 PM
Study NCT ID:
NCT06260735
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Spinal Cord Stimulation After Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurophysiological markers or stepping', 'timeFrame': 'Pre-training (on week 1) and within one week from end of training (on week 6)', 'description': 'Average step length, step height at ankle (cm).'}, {'measure': 'Electromyography (EMG) of ankle extensor muscles', 'timeFrame': 'Pre-training (on week 1) and within one week from end of training (on week 6)', 'description': 'Mean RMS amplitude'}, {'measure': 'Metabolic function testing', 'timeFrame': 'Pre-training (on week 1) and within one week from end of training (on week 6)', 'description': 'Breath-by-breath analysis of air in/out will be used to measure VO2max (mL/kg/min).'}], 'secondaryOutcomes': [{'measure': '6 Min Walk Test', 'timeFrame': 'Pre-training (on week 1) and within one week from end of training (on week 6)', 'description': 'Measure distance (m) covered in 6 min walking, overground with device of choice (if using it at home/in community). Repeat with save device. Verbal encouragement and safety support in place during testing.'}, {'measure': 'SCIM-Spinal Cord Independence Measure- Mobility scores', 'timeFrame': 'Pre-training (on week 1) and within one week from end of training (on week 6)', 'description': 'Rick Hansen Institute, Spinal Cord Independence Measure III - Mobility subsection, Questions 12-17. Scale: 0-20. Lower score means less mobility.'}, {'measure': 'Autonomic scores', 'timeFrame': 'Pre-training (on week 1) and within one week from end of training (on week 6)', 'description': 'American Spinal Injury Association-Autonomic Standards assessment form-General Autonomic Function \\& Lower Urinary tract, bowel, and sexual function components. Scale: 0-48. Lower scores mean less autonomic function.'}, {'measure': 'Rate or Perceived Exertion (RPE) of Submaximal VO2 testing', 'timeFrame': 'Pre-training (on week 1) and within one week from end of training (on week 6)', 'description': 'Borg scale from 6-20 (chart used from Heart Online open source). Scale: 6-20. Lower scores mean less exertion (less tiring).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trans-spinal electrical stimulation', 'Locomotor training', 'Functional electrical stimulation', 'Peripheral nerve stimulation'], 'conditions': ['Spinal Cord Injuries', 'Spinal Cord Diseases']}, 'descriptionModule': {'briefSummary': 'Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.\n\nThis project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.', 'detailedDescription': 'This project will evaluate the effects of non-invasive lumbar ts-ES on locomotor function in people with incomplete motor SCI (iSCI) who retain some ability to stand or walk.\n\nThis study has 3 phases:\n\nBaseline assessment - 2 sessions - week 1 -Lab visits #1-2\n\nLocomotor training with varied electrical stimulation- 12 sessions - weeks 2-5 - Lab visits #3-14 (1hr, x3/week)\n\nEnd of training assessment - 2 sessions - week 6- Lab visits #15-16.\n\nSpecific locomotor deficits of each participant will be evaluated, and their step-cycle-based peripheral muscle or nerve stimulation strategy will be determined accordingly to improve stance or step capacity. After augmenting their locomotor function with muscle or peripheral nerve stimulation-induced activation strategies that address particular and unique motor deficits, they will receive intermittent bouts of stance or locomotor training supplemented with ts-ES. The locomotor training will consist of standing/walking on a treadmill with appropriate bodyweight support and added muscle or peripheral nerve stimulation.\n\nSpecifically, the project aims to assess the following:\n\n1. Does combined muscle (NMES) or peripheral nerve (PN) stimulation with ts-ES during treadmill stepping facilitate locomotor performance?\n2. Does four weeks of combined training as described above (1hrx3/week) facilitate exercise capacity (measured by submaximal VO2) in persons with chronic iSCI?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has spinal cord injury, 6 mo or longer since injury\n* Is between 20 and 65 years of age\n* Has difficulty with trunk and/or lower limb function\n* Stable medical condition\n* Non-progressive etiology of spinal injury\n* No ventilatory support\n\nExclusion Criteria:\n\n* Genetic or degenerative etiology of spinal injury\n* Need for ventilatory or other life-sustaining medical support\n* History of cardiovascular or pulmonary complications (heart failure, severe hypertension etc.)'}, 'identificationModule': {'nctId': 'NCT06260735', 'acronym': 'SCI-ES-WALK', 'briefTitle': 'Non-invasive Spinal Cord Stimulation After Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Non-invasive Spinal Cord Stimulation for Improving Movement: Neuromodulation With Spinal Stimulation Methods and Individualized Locomotor Training', 'orgStudyIdInfo': {'id': 'HS25897 (H2023:073)'}, 'secondaryIdInfos': [{'id': 'URGP#51472', 'type': 'OTHER_GRANT', 'domain': 'University of Manitoba'}, {'id': 'RGPIN-2015-05703', 'type': 'OTHER_GRANT', 'domain': 'NSERC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill training combined with muscle and spinal cord stimulation', 'description': 'Locomotor training is defined as walking on a treadmill with appropriate bodyweight support and augmented with muscle activation either by electrical nerve or muscle stimulation based on individual needs. Then, spinal stimulation will be integrated during training with on/off bouts alternating.', 'interventionNames': ['Device: Trans-spinal electrical stimulation', 'Device: Electrical muscle activation', 'Other: Treadmill walking']}], 'interventions': [{'name': 'Trans-spinal electrical stimulation', 'type': 'DEVICE', 'description': 'Trans-spinal electrical stimulation (ts-ES) at T11-L1 vertebral levels with short pulses at a set frequency (30Hz).', 'armGroupLabels': ['Treadmill training combined with muscle and spinal cord stimulation']}, {'name': 'Electrical muscle activation', 'type': 'DEVICE', 'description': 'Peripheral nerve (PN) or muscle (NMES) stimulation strategy was developed for each participant to optimize stance/walk capacity based on personal needs/preferences.', 'armGroupLabels': ['Treadmill training combined with muscle and spinal cord stimulation']}, {'name': 'Treadmill walking', 'type': 'OTHER', 'description': 'Stepping on a treadmill with individually preferred speed.', 'armGroupLabels': ['Treadmill training combined with muscle and spinal cord stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3E 0W2', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Katinka Stecina', 'role': 'CONTACT', 'email': 'katinka.stecina@umanitoba.ca', 'phone': '204-789-3761'}], 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Katinka Stecina', 'role': 'CONTACT', 'email': 'katinka.stecina@umanitoba.ca', 'phone': '204-789-3761'}, {'name': 'Kristine Cowley', 'role': 'CONTACT', 'email': 'kristine.cowley@umanitoba.ca', 'phone': '204-789-3305'}], 'overallOfficials': [{'name': 'Katinka Stecina', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}, {'name': 'Kristine Cowley', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Katinka Stecina', 'investigatorAffiliation': 'University of Manitoba'}}}}