Status:
COMPLETED
Non-invasive Cervical Electrical Stimulation for SCI
Lead Sponsor:
Bronx VA Medical Center
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Most spinal cord injuries (SCI) are anatomically incomplete - some nerve circuits remain intact, even if the individual cannot feel or control them. Activating spared nerve circuits may improve functi...
Detailed Description
Roughly 60% of spinal cord injuries occur at the cervical level. Most injuries are anatomically incomplete. Activating spared nerve circuits augments functional recovery of the damaged nervous system....
Eligibility Criteria
Inclusion
- Age between 18 and 75 years;
- Chronic (more than 12 months since injury) incomplete SCI between levels C2-C8.
- Incomplete weakness of left or right hand muscles: score of 2, 3, or 4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction;
- Detectable F-wave responses of the left or right abductor pollicis brevis muscle to median nerve stimulation.
- US Veteran or non-Veteran
Exclusion
- History of other serious injury or disease of central or peripheral nervous system
- History of seizures
- Ventilator dependence or patent tracheostomy site
- Use of medications that significantly lower seizure threshold
- History of head trauma with 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 (millimeters of mercury) 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 or suicide attempt or active psychosis
- Heavy alcohol consumption (\> equivalent of 5 ounces 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 :
August 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03414424
Start Date
August 22 2017
End Date
April 30 2021
Last Update
November 29 2023
Active Locations (1)
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1
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468