Status:
RECRUITING
Finding the Best Combination of Brain and Spinal Cord Stimulation With Hand Training After Spinal Cord Injury
Lead Sponsor:
Bronx VA Medical Center
Collaborating Sponsors:
Bronx Veterans Medical Research Foundation, Inc
New York State Department of Health
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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" - w...
Detailed Description
See above.
Eligibility Criteria
Inclusion
- Age between 18-85 years.
- 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
- Personal or extensive family history of seizures;
- 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.
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06104735
Start Date
May 24 2024
End Date
December 31 2026
Last Update
October 22 2025
Active Locations (1)
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1
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468