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Recruiting EARLY_Phase 1 NCT05163639

NCT05163639 Spinal Cord Associative Plasticity Study

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Clinical Trial Summary
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 2026-06-30

Trial Parameters

Condition Cervical Spinal Cord Injury
Sponsor Columbia University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 92
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2021-09-10
Completion 2026-06-30
Interventions
Non-invasive pairing of cortical and spinal stimulationIntraoperative pairing of cortical and spinal stimulationNon-invasive repeated pairing of cortical and spinal stimulation (SCAP)

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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 t

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