Status:
COMPLETED
Brain Plus Spinal Stimulation for Cervical SCI
Lead Sponsor:
Bronx VA Medical Center
Collaborating Sponsors:
New York State Department of Health
Conditions:
Spinal Cord Injuries
Spinal Cord Injury at C5-C7 Level
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this project is to strengthen residual corticospinal tract (CST) connections after partial injury using combined motor cortex and spinal cord stimulation to improve arm and hand function a...
Detailed Description
For people with cervical SCI, regaining hand function is their highest priority. Most SCIs are motor incomplete, and even when complete, there is often significant amounts of spared spinal cord white ...
Eligibility Criteria
Inclusion
- Able-bodied participants
- Age between 18 and 75 years;
- No known central or peripheral neurological disease or injury.
- SCI participants
- Age between 18 and 75 years;
- Chronic (\> 12 months) SCI between neurological levels C1-C8;
- Score of 2, 3, or 4 (out of 5) on manual muscle testing of elbow flexion, wrist extension, wrist flexion, finger extension, finger flexion, or finger abduction in left or right hand;
Exclusion
- Multiple spinal cord lesions;
- History of seizures;
- Ventilator dependence or patent tracheostomy site;
- Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, or brain abscess;
- History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
- Significant coronary artery or cardiac conduction disease;
- 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 bipolar disorder;
- History of suicide attempt;
- Active psychosis;
- Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) within previous 48 hours;
- Open skin lesions over the face, neck, shoulders, or arms;
- Pregnancy;
- Unsuitable for study participation as determined by study physician.
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04727866
Start Date
January 4 2021
End Date
January 13 2024
Last Update
January 17 2024
Active Locations (1)
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1
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, United States, 10468