Brain and Nerve Stimulation for Hand Muscles in Spinal Cord Injury and ALS
Completed · Not applicable
Conditions studied: Spinal Cord Injury (SCI), Amyotrophic Lateral Sclerosis (ALS)
In brief
Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits may be an important method to improve functional recovery. In this study, the investigators aim to use non-invasive magnetic and electrical stimulation to strengthen motor circuits between the brain and hands. Magnetic stimulation will be used over the motor cortex (scalp). Two methods of electrical stimulation will be compared: stimulation of the median nerve at the wrist; or direct stimulation of the cervical spinal cord across the skin on the back of the neck. Several different combinations of magnetic and electrical stimulation will be compared to find the conditions that best strengthen nerve circuits between the brain and hands - "Fire Together, Wire Together". PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS STUDY. If we see temporary changes in this study, then future studies would focus on how to prolong that effect.
Key facts
- Study ID
- NCT02469675
- Run by
- Bronx VA Medical Center
- People needed
- 39
- Starts
- 2015-06-01
- Expected to finish
- 2018-07-31
- Last updated by the study team
- 2018-10-01
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females age 21-65 years;
- No history of serious neurological injury or disease; OR
- Chronic (>12 months since injury) incomplete SCI between levels C2-C8 or diagnosis of definite or probable ALS;
- Incomplete weakness of left or right hand muscles: score of 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;
- Detectable motor evoked potentials in left or right abductor pollicis brevis muscle to transcranial magnetic stimulation.
You may not qualify if…
- 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 to 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;
- Recurrent history over the last 6 months of autonomic dysreflexia;
- 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.
Where it is running
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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