Status:
TERMINATED
EMG Triggered Closed-Loop Stimulation for Spinal Cord Injury Individuals
Lead Sponsor:
Bronx VA Medical Center
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Most individuals with spinal cord injury (SCI) have residual nerve circuits. The investigators aim to strengthen those circuits to improve motor recovery after injury. To do this, the investigators ar...
Detailed Description
In both animal models and humans with spinal cord injury (SCI), synaptic efficacy between corticospinal axons and spinal motor neurons has improved temporarily after a short period of paired stimulati...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years;
- Chronic (more than 12 months since injury) motor-incomplete SCI between neurological levels C2-C8
- Score of 3 or more (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand;
- Detectable F-wave responses of the left or right abductor pollicis brevis (APB) to median nerve stimulation;
- Detectable motor evoked potentials in left or right APB;
- Able to perform thumb-middle finger opposition pinch task with detectable APB EMG muscle activity.
Exclusion
- Multiple spinal cord lesions;
- History of seizures;
- Ventilator dependence or patent tracheostomy site;
- Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, brain abscess, or multiple sclerosis;
- 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 :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03806023
Start Date
February 1 2018
End Date
February 28 2020
Last Update
October 5 2020
Active Locations (1)
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1
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468