Phase
Condition
Spinal Cord Injuries
Treatment
CPH + hand training
CD-LD + hand training
Placebo + hand training
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female between 18 and 65 years of age; clinically stable chronic (> 12months) SCI at or above C8 spinal segment;
Motor-incomplete with a score of 2 or more (out of 5) on manual muscle testing (MMT)of finger extension, finger flexion, or finger abduction in left or right hand(s);or able to perform thumb-index finger pinch of the left or right hand;
Detectable stimulation-evoked muscle responses of the left or right first dorsalinterosseous (FDI) and/or abductor pollicis brevis (APB); Detectable FDI/APB surfaceelectromyography (EMG) muscle activity during thumb-index finger pinch;
Must have stable: medication [≥ 30 days prior]; rehabilitation regimen [≥ 15 daysprior];
Must be able to: abstain from alcohol, smoking and caffeine consumption on the dayprior/of each experiment; abstain from recreational drugs for the entirety of thestudy; commit to study requirements (i.e., 7 visits); provide informed consent.
Exclusion
Exclusion Criteria:
History of moderate or severe head trauma (loss of consciousness for greater thanone hour or evidence of brain contusion or hemorrhage or depressed skull fracture onprior imaging);
History of other serious central or peripheral neurological injury;
History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagneticmetallic implants in the head (except inside mouth); cochlear implants; cardiacpacemaker/defibrillator; intracardiac lines; currently increased intracranialpressure; or other contraindications to brain stimulation or task performance;
Ventilator dependence or patent tracheostomy site;
Unstable syrinx, or multiple spinal cord lesions;
Unclear diagnosis; History of stroke, brain tumor, brain abscess, or multiplesclerosis;
Personal history of seizures; extensive family history of seizures; use ofmedications that lower seizure threshold (e.g., amphetamines, dalfampridine, andbupropion);
Use of the study medications; Use of medications known to have significant adverseinteractions with the study medication as described in the manufacturers'prescribing information [14 days prior]; previous allergic reaction orhypersensitivity to study drug(s);
Presence of a medical condition that represents a risk for study drug(s)administration; evidence of liver disease or clinical jaundice; neutropenia;glaucoma; gastrointestinal ulcer(s); active malignancy; undiagnosed skin lesions;autoimmune disorders; chronic infectious diseases (e.g. HIV, hepatitis B or C);pregnancy or nursing mothers (a pregnancy urine test may be warranted); neurologicdisorders (including a history of serious head trauma or seizures), and uncontrolledcardiovascular, metabolic, pulmonary or renal disease; premorbid, ongoing majordepression or psychosis, altered cognitive status; bipolar disorder; suicidalideation or past suicide attempts;
History of severe hearing problems, loss or tinnitus;
Presence of urinary infection, fever, pressure ulcer; or open skin lesions (shoulders or arms);
Recent history (< 6 months) of recurrent autonomic dysreflexia, defined as asyndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolicpressure greater than 10 mm Hg, without rise in HR, accompanied by symptoms such asheadache, facial flushing, sweating, nasal congestion, and blurry vision (closelymonitored during all testing procedures);
Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) withinprevious 48 hours;
Recent history (>1 year) of chemical substance dependency or significantpsychosocial disturbance;
Study participation of an investigational drug or device [60 days prior];
Unsuitable for study participation as determined by the study physician.
Study Design
Study Description
Connect with a study center
James J. Peters Veterans Affairs Medical Center
Bronx, New York 10468
United StatesActive - Recruiting
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