Finding the Best Combination of Brain and Spinal Cord Stimulation With Hand Training After Spinal Cord Injury
NCT ID: NCT06104735
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2024-05-24
2026-12-31
Brief Summary
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This 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?
The 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.
Regaining 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All participants
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.
Synaptic Pairing Interval
Optimize interstimulus pairing between brain and spinal cord stimulation.
Frequency
Compare 2 Hz continuous to intermittent theta burst frequency
Bouts
Compare effects of 1, 2, or 4 bouts of SCAP
Spacing
Compare 6 versus 12 minutes of rest in between bouts of SCAP
Exercise
Task-oriented hand exercises
SCAP plus Exercise
Compare interleaved versus serial bouts of SCAP and exercise.
Interventions
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Synaptic Pairing Interval
Optimize interstimulus pairing between brain and spinal cord stimulation.
Frequency
Compare 2 Hz continuous to intermittent theta burst frequency
Bouts
Compare effects of 1, 2, or 4 bouts of SCAP
Spacing
Compare 6 versus 12 minutes of rest in between bouts of SCAP
Exercise
Task-oriented hand exercises
SCAP plus Exercise
Compare interleaved versus serial bouts of SCAP and exercise.
Eligibility Criteria
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Inclusion Criteria
* Must have stable prescription medication for 30 days prior to screening
* 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.
* Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.
Exclusion Criteria
* Ventilator dependence or patent tracheostomy site;
* History of stroke, brain tumor, brain abscess, or multiple sclerosis;
* History of severe head trauma requiring neurosurgery;
* 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;
* 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;
* 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);
* History of significant hearing problems;
* History of bipolar disorder;
* History of suicide attempt;
* Active psychosis;
* Recent history (\>1 year) of chemical substance dependency or significant psychosocial disturbance;
* Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;
* Open skin lesions over the face, neck, shoulders, or arms;
* Pregnancy; and
* Unsuitable for study participation as determined by study physician.
18 Years
85 Years
ALL
No
Sponsors
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Bronx Veterans Medical Research Foundation, Inc
OTHER
New York State Department of Health
OTHER_GOV
Bronx VA Medical Center
FED
Responsible Party
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Noam Y. Harel
Principal Investigator
Principal Investigators
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Noam Y Harel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
JAMES J. PETERS VAMC
Locations
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James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1777667
Identifier Type: -
Identifier Source: org_study_id
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