Actively Recruiting
Spinal Cord Associative Plasticity Study Evaluating Combined Brain and Spinal Stimulation for Cervical Spinal Cord Injury and Surgery
Led by Columbia University · Updated on 2026-05-13
92
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating spinal cord associative plasticity (SCAP), a combined brain and spinal electrical stimulation technique aimed at improving arm and hand function in people with cervical spinal cord injury (SCI). The study focuses on understanding how electrical stimulation can strengthen spinal cord signaling, improve spinal cord function especially after surgery, and explore its effects in both injured and uninjured spinal cords. This early phase study includes participants with chronic SCI, cervical myelopathy, and uninjured volunteers. Participants will undergo different types of paired cortical and spinal stimulation, either non-invasive or during cervical spine surgery. The interventions include measuring motor thresholds and timing stimulation pulses to enhance spinal connections. Some participants will experience repeated pairing of stimulation (SCAP) to assess lasting effects, both in surgery and non-invasive settings. Control conditions involve single or non-convergent stimulations to compare with paired stimulation. During the study, participants will attend up to seven visits where muscle responses, pinch force, and nerve reflexes are measured before, immediately after, and up to one hour following stimulation. Assessments include brain and spinal cord stimulation thresholds, muscle activity recordings, and manual muscle testing. Safety monitoring includes seizure risk screening and medication review. The total participation duration varies depending on individual schedules and surgical timing.
CONDITIONS
Brief Title
Spinal Cord Associative Plasticity Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Stable prescription medication for at least 30 days before screening
- Able to abstain from alcohol, smoking, and caffeine on experiment days
- Able to avoid recreational drugs during the entire study
- Willing to commit to all study visits (7 visits)
- Able to provide informed consent
- For able-bodied participants: no known central or peripheral neurological disease or injury
- For spinal cord injury participants: manual muscle testing score of 1-4 out of 5 in finger extension, flexion, or abduction in either hand
- For intraoperative participants: clinical indication for cervical spine surgery
You will not qualify if you...
- Personal or extensive family history of seizures
- Dependence on ventilator or open tracheostomy site
- 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 significant brain injury
- Implanted brain, spine, or nerve stimulators; aneurysm clips; ferromagnetic implants in the head (except inside mouth); cochlear implants; cardiac pacemaker or defibrillator
- Increased intracranial pressure or other contraindications to brain or spine stimulation
- Significant coronary artery or cardiac conduction disease
- Recent myocardial infarction or heart failure with low ejection fraction or severe symptoms
- Recent recurrent autonomic dysreflexia within 6 months
- Significant hearing problems
- History of bipolar disorder or suicide attempt
- Active psychosis
- Recent history (over 1 year) of chemical substance dependency or major psychosocial disturbance
- Heavy alcohol use within 48 hours before study visits
- Open skin lesions on face, neck, shoulders, or arms
- Pregnancy
- Unsuitable for study participation as determined by study physician
- For cortical stimulation experiments: epilepsy, skull surgery with metal implants, cochlear implants, aneurysm stents, skull shrapnel
- For spinal cord stimulation experiments: stimulation devices in neck or chest (e.g., vagal nerve stimulator, pacemaker)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
7 visits
Duration - Single session with assessments lasting up to 1 hour after stimulation
Participants undergo non-invasive pairing of cortical and spinal stimulation to examine immediate and lasting effects on hand muscle response.
1 to multiple visits depending on intervention schedule
Duration - Duration of surgery
Participants scheduled for cervical spine surgery receive paired cortical and spinal stimulation during surgery to examine immediate effects.
1 visit (intraoperative)
Duration - Duration of surgery
Participants undergoing cervical surgery receive repeated cortical and spinal stimulation during surgery to examine lasting effects of stimulation.
1 visit (intraoperative)
Duration - Multiple sessions over study period with assessments immediately and up to 1 hour after each session
Participants receive repeated non-invasive cortical and spinal stimulation sessions to study lasting effects on muscle responses and hand function.
Multiple visits for repeated stimulation and follow-up assessments
Duration - Duration of surgery
Participants undergoing surgery receive repeated paired stimulation targeted at or below the myelopathic region to examine lasting effects.
1 visit (intraoperative)
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
Research Team
J
Jason B Carmel, M.D., Ph.D.
N
Noam Y Harel, M.D., Ph.D.
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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