Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT06104735
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2023-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Finding the Best Combination of Brain and Spinal Cord Stimulation With Hand Training After Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'C102196', 'term': 'SREBP cleavage-activating protein'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each participant will undergo multiple conditions and verifications in an "n-of-1" design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of motor evoked potential at the target muscle.', 'timeFrame': 'Through study completion, up to 10 months', 'description': 'The primary neurophysiological outcome will be corticospinal excitability measured at the target muscle. The target muscle will be determined during the first evaluation session, with preference for first dorsal interosseous (FDI), abductor pollicis brevis (APB), or extensor carpi radialis (ECR) muscles based on muscle excitability and consistency. TMS recruitment curves will be collected. The amplitude of target muscle responses to TMS and spinal cord stimulation will be compared after the various interventions.'}], 'secondaryOutcomes': [{'measure': 'Pinch and grip strength', 'timeFrame': 'Through study completion, up to 10 months', 'description': 'Maximal isometric pinch strength will be measured in key-pinch (lateral edge of the index finger and the thumb) and tip-to-tip (tips of first and third finger) configurations using a pinch dynamometer. Grip strength will be measured using a hand dynamometer. For each type of pinch or grip, three trials will be conducted by holding the dynamometer with maximal volitional force for 3-5 seconds, with at least 30 seconds or more between trials. The highest achieved value will be used for analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neuromodulation', 'spinal cord stimulation', 'task-oriented exercise', 'transcranial magnetic stimulation'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'While physical exercise remains the foundation for any rehabilitation therapy, the team seeks to improve the benefits of exercise by combining it with the concept of "Fire Together, Wire Together" - when brain stimulation is synchronized with spinal cord stimulation, nerve circuits in the spinal cord strengthen - a phenomenon termed "Spinal Cord Associative Plasticity", or SCAP.\n\nThis project will build on the team\'s promising preliminary findings. When one pulse of brain stimulation is synchronized with one pulse of cervical spinal stimulation, hand muscle responses are larger than with brain stimulation alone or unsynchronized stimulation. However, the team does not know the best ways to apply SCAP repetitively, especially in conjunction with exercise, to increase and extend improvements in clinical function. Do ideal intervention parameters vary across individuals, or do they need to be customized?\n\nThe team will take a systematic approach with people who have chronic cervical SCI to determine each person\'s best combination of SCAP with task-oriented hand exercise. Participants will undergo up to 53 intervention, verification, and follow-up sessions over a period of 6 to 10 months each. The team will measure clinical and physiological responses of hand and arm muscles to each intervention.\n\nRegaining control over hand function represents the top priority for individuals with cervical SCI. Furthermore, this approach could be compatible with other future interventions, including medications and cell-based treatments.', 'detailedDescription': 'See above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-85 years.\n* Must have stable prescription medication for 30 days prior to screening\n* Must be able to: abstain from alcohol, smoking and heavy caffeine consumption on the day of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 53 visits); provide informed consent.\n* Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.\n\nExclusion Criteria:\n\n* Personal or extensive family history of seizures;\n* Ventilator dependence or patent tracheostomy site;\n* History of stroke, brain tumor, brain abscess, or multiple sclerosis;\n* History of severe head trauma requiring neurosurgery;\n* History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation;\n* Significant coronary artery or cardiac conduction disease; recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV;\n* Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);\n* History of significant hearing problems;\n* History of bipolar disorder;\n* History of suicide attempt;\n* Active psychosis;\n* Recent history (\\>1 year) of chemical substance dependency or significant psychosocial disturbance;\n* Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;\n* Open skin lesions over the face, neck, shoulders, or arms;\n* Pregnancy; and\n* Unsuitable for study participation as determined by study physician.'}, 'identificationModule': {'nctId': 'NCT06104735', 'briefTitle': 'Finding the Best Combination of Brain and Spinal Cord Stimulation With Hand Training After Spinal Cord Injury', 'organization': {'class': 'FED', 'fullName': 'Bronx VA Medical Center'}, 'officialTitle': 'Optimizing Spinal Cord Associative Plasticity to Enhance Response to Hand Training in Cervical Spinal Cord Injury', 'orgStudyIdInfo': {'id': '1777667'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All participants', 'description': 'Each participant will undergo varying conditions in separate phases to determine optimal: Pairing interval; Frequency; Number of bouts, Inter-bout spacing, and the order of SCAP when given in conjunction with task-oriented hand exercise.', 'interventionNames': ['Procedure: Synaptic Pairing Interval', 'Procedure: Frequency', 'Procedure: Bouts', 'Procedure: Spacing', 'Procedure: Exercise', 'Procedure: SCAP plus Exercise']}], 'interventions': [{'name': 'Synaptic Pairing Interval', 'type': 'PROCEDURE', 'description': 'Optimize interstimulus pairing between brain and spinal cord stimulation.', 'armGroupLabels': ['All participants']}, {'name': 'Frequency', 'type': 'PROCEDURE', 'description': 'Compare 2 Hz continuous to intermittent theta burst frequency', 'armGroupLabels': ['All participants']}, {'name': 'Bouts', 'type': 'PROCEDURE', 'description': 'Compare effects of 1, 2, or 4 bouts of SCAP', 'armGroupLabels': ['All participants']}, {'name': 'Spacing', 'type': 'PROCEDURE', 'description': 'Compare 6 versus 12 minutes of rest in between bouts of SCAP', 'armGroupLabels': ['All participants']}, {'name': 'Exercise', 'type': 'PROCEDURE', 'description': 'Task-oriented hand exercises', 'armGroupLabels': ['All participants']}, {'name': 'SCAP plus Exercise', 'type': 'PROCEDURE', 'description': 'Compare interleaved versus serial bouts of SCAP and exercise.', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Francisco Castano, MPH', 'role': 'CONTACT', 'email': 'francisco.castano@va.gov', 'phone': '718-584-9000', 'phoneExt': '5824'}, {'name': 'Noam Y. Harel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'James J. Peters VA Medical Center, Bronx, NY', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'centralContacts': [{'name': 'Francisco Castano, MPH', 'role': 'CONTACT', 'email': 'francisco.castano@va.gov', 'phone': '718-584-9000', 'phoneExt': '5824'}], 'overallOfficials': [{'name': 'Noam Y Harel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JAMES J. PETERS VAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bronx VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Bronx Veterans Medical Research Foundation, Inc', 'class': 'OTHER'}, {'name': 'New York State Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Noam Y. Harel', 'investigatorAffiliation': 'Bronx VA Medical Center'}}}}