Phase
Condition
Spinal Cord Injuries
Limb Spasticity
Spinal Cord Disorders
Treatment
Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region
Non-invasive pairing of cortical and spinal stimulation
Intraoperative repeated pairing of cortical and spinal stimulation (SCAP)
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
NON-INVASIVE
Inclusion Criteria:
(All participants)
Age between 18-80 years.
Must have stable prescription medication for 30 days prior to screening
Must be able to: abstain from alcohol, smoking and caffeine consumption on the dayof each experiment; abstain from recreational drugs for the entirety of the study;commit to study requirements (i.e., 7 visits); provide informed consent.
(Able-bodied participants)
- No known central or peripheral neurological disease or injury.
(SCI participants - including patients scheduled for intraoperative procedures)
- Score of 1-4 (out of 5) on manual muscle testing of finger extension, fingerflexion, or finger abduction in left or right hand.
Exclusion
Exclusion criteria:
(All participants)
Personal or extensive family 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, brain abscess, or multiple sclerosis;
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 implanted brain/spine/nerve stimulators, aneurysm clips, ferromagneticmetallic implants in the head (except for inside mouth); cochlear implants; cardiacpacemaker/defibrillator; intracardiac lines; currently increased intracranialpressure; or other contraindications to brain or spine stimulation;
Significant coronary artery or cardiac conduction disease; recent history ofmyocardial infarction and heart failure with an ejection fraction of less than 30%or with a New York Heart Association Functional Classification of Class III or IV;
Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined asa syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolicpressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptomssuch as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);
History of significant hearing problems;
History of bipolar disorder;
History of suicide attempt;
Active psychosis;
Recent history (>1 year) of chemical substance dependency or significantpsychosocial disturbance;
Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;
Open skin lesions over the face, neck, shoulders, or arms;
Pregnancy; and
Unsuitable for study participation as determined by study physician.
INTRA-OPERATIVE
Inclusion Criteria:
- Clinical indication for cervical spine surgery.
Exclusion criteria:
(For experiments involving cortical stimulation)
Epilepsy;
A history of skull surgery with metal implants;
Cochlear implants;
Patients with aneurysm stents in neck or brain blood vessels;
Evidence of skull shrapnel; (For experiments involving spinal cord stimulation)
Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiacpatients with pacemakers)
Study Design
Study Description
Connect with a study center
Bronx Veterans Medical Research Foundation, Inc
New York, New York 10029
United StatesActive - Recruiting
Columbia University Irving Medical Center
New York, New York 10032
United StatesActive - Recruiting
Weill Cornell Medicine
New York, New York 10065
United StatesActive - Recruiting
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