Spinal Cord Associative Plasticity Study for Spinal Cord Injury

This study is looking at ways to improve arm and hand function in people with cervical spinal cord injury (SCI), tetraplegia/tetraparesis, or cervical myelopathy. Researchers are testing different methods of combining brain and spinal cord stimulation. This includes non-invasive (outside the body) and intraoperative (during surgery) techniques called "Spinal Cord Associative Plasticity" (SCAP). The goal is to see if these methods can strengthen the signals from the brain to the muscles and improve our understanding of how the spinal cord works. You may be eligible if you are 18-80 years old and can meet certain study requirements. Success will be measured by changes in hand muscle response to brain stimulation immediately after these procedures.

Study design
This interventional study plans to enroll 92 participants. It is not specified if it is randomized or blinded.
What's involved
You would need to attend 7 visits and abstain from alcohol, smoking, and caffeine on experiment days, and recreational drugs for the study duration.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured immediately after the stimulation procedures, so long-term follow-up is not specified.

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NCT05163639

Spinal Cord Associative Plasticity Study

Recruiting
EARLY_PHASE1Ages 18–80InterventionalBasic science
Columbia University
~92 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Non-invasive pairing of cortical and spinal stimulationIntraoperative pairing of cortical and spinal stimulationNon-invasive repeated pairing of cortical and spinal stimulation (SCAP)Intraoperative repeated pairing of cortical and spinal stimulation (SCAP)Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Size of hand muscle response to brain stimulation during combined brain and spinal stimulation
Measured over Immediate
+1 more outcome measured
Cervical Spinal Cord Injury
Tetraplegia/Tetraparesis
Cervical Myelopathy
3 sites across 1 states
New York3
  • Jason B Carmel, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Columbia University

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Eligibility criteria

Inclusion

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 day of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 7 visits); provide informed consent.
No known central or peripheral neurological disease or injury.
Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.
Clinical indication for cervical spine surgery.

Exclusion

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 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 in the head (except for inside mouth); cochlear implants; cardiac pacemaker/defibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation;
Significant coronary artery or cardiac conduction disease; recent history of myocardial 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 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 significant hearing problems;
History of bipolar disorder;
History of suicide attempt;
Active psychosis;
Recent history (\>1 year) of chemical substance dependency or significant psychosocial 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.
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, cardiac patients with pacemakers)
  • Size of hand muscle response to brain stimulation during combined brain and spinal stimulationImmediate

    Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the muscle response for brain only stimulation. This applies to Arms 1-2.

  • Size of hand muscle response to brain stimulation after SCAPImmediately after SCAP

    Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the equivalent measure taken before the SCAP protocol. This applies to Arms 3-5.