Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT05163639

Spinal Cord Associative Plasticity Study

Led by Columbia University · Updated on 2026-05-13

92

Participants Needed

3

Research Sites

250 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Spinal cord associative plasticity (SCAP) is a combined cortical and spinal electrical stimulation technique developed to induce recovery of arm and hand function in spinal cord injury. The proposed study will advance understanding of SCAP, which is critical to its effective translation to human therapy. The purpose of the study is to: 1. Determine whether signaling through the spinal cord to the muscles can be strengthened by electrical stimulation. 2. Improve our understanding of the spinal cord and how it produces movement. 3. Determine whether spinal surgery to relieve pressure on the spinal cord can improve its function. Aim 1 is designed to advance mechanistic understanding of spinal cord associative plasticity (SCAP). Aim 2 will determine whether SCAP increases spinal cord excitability after the period of repetitive pairing. In rats, SCAP augments muscle activation for hours after just 5 minutes of paired stimuli. Whereas Aims 1 and 2 focused on the effects of paired stimulation in the context of uninjured spinal cord, Aim 3 assesses whether paired stimulation can be effective across injured cord segments. Aim 3 will incorporate the experiments from Aim 1 and 2 but in people with SCI, either traumatic or pre-operative patients with myelopathy in non-invasive experiments, or targeting myelopathic segments in intraoperative segments.

CONDITIONS

Official Title

Spinal Cord Associative Plasticity Study

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18-80 years
  • Stable prescription medication for 30 days prior to screening
  • Ability to abstain from alcohol, smoking, and caffeine on experiment days
  • Abstain from recreational drugs for the entire study
  • Commitment to study requirements including 7 visits
  • Ability to provide informed consent
  • No known central or peripheral neurological disease or injury (able-bodied participants only)
  • Score of 1-4 on manual muscle testing of finger extension, flexion, or abduction in left or right hand (SCI participants including those scheduled for surgery)
  • Clinical indication for cervical spine surgery (intra-operative participants)
Not Eligible

You will not qualify if you...

  • Personal or extensive family history of seizures
  • Ventilator dependence or patent tracheostomy
  • Use of medications that lower seizure threshold (e.g., amphetamines, neuroleptics, dalfampridine, bupropion)
  • History of stroke, brain tumor, brain abscess, or multiple sclerosis
  • History of moderate or severe head trauma with prolonged unconsciousness or brain injury seen on imaging
  • Implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic implants in the head (except inside mouth), cochlear implants, cardiac pacemaker/defibrillator, intracardiac lines
  • Increased intracranial pressure or other contraindications to brain or spine stimulation
  • Significant coronary artery or cardiac conduction disease, recent myocardial infarction, or severe heart failure
  • Recent recurrent autonomic dysreflexia within past 6 months
  • Significant hearing problems
  • History of bipolar disorder, suicide attempt, active psychosis
  • Recent chemical substance dependency or significant psychosocial disturbance within past year
  • Heavy alcohol use within 48 hours prior
  • Open skin lesions over face, neck, shoulders, or arms
  • Pregnancy
  • Unsuitable for study as determined by physician
  • Epilepsy or skull surgery with metal implants (for cortical stimulation experiments)
  • Cochlear implants or aneurysm stents in neck or brain blood vessels (for cortical stimulation)
  • Stimulation devices in neck or chest such as vagal nerve stimulators or pacemakers (for spinal cord stimulation)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Bronx Veterans Medical Research Foundation, Inc

New York, New York, United States, 10029

Actively Recruiting

2

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

3

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

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Research Team

J

Jason B Carmel, M.D., Ph.D.

CONTACT

N

Noam Y Harel, M.D., Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

5

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