NCT05163639 Spinal Cord Associative Plasticity Study
| NCT ID | NCT05163639 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Columbia University |
| Condition | Cervical Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2021-09-10 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 92 participants in total. It began in 2021-09-10 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 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. (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, finger flexion, or finger abduction in left or right hand. 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 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. 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, cardiac patients with pacemakers)
Contact & Investigator
Jason B Carmel, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05163639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cervical Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05163639 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05163639 currently recruiting?
Yes, NCT05163639 is actively recruiting participants. Contact the research team at jbc28@cumc.columbia.edu for enrollment information.
Where is the NCT05163639 trial being conducted?
This trial is being conducted at New York, United States, New York, United States, New York, United States.
Who is sponsoring the NCT05163639 clinical trial?
NCT05163639 is sponsored by Columbia University. The principal investigator is Jason B Carmel, M.D., Ph.D. at Columbia University. The trial plans to enroll 92 participants.