Spinal Cord Associative Plasticity Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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: Determine whether signaling through the spinal cord to the muscles can be strengthened by electrical stimulation. Improve our understanding of the spinal cord and how it produces movement. 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: Accepts Healthy Volunteers
View:

• (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.

• Clinical indication for cervical spine surgery.

Locations
United States
New York
Bronx Veterans Medical Research Foundation, Inc
Recruiting
New York
Columbia University Irving Medical Center
Recruiting
New York
Weill Cornell Medicine
Not yet recruiting
New York
Contact Information
Primary
Jason B Carmel, M.D., Ph.D.
jbc28@cumc.columbia.edu
917-301-1882
Backup
Noam Y Harel, M.D., Ph.D.
noam.harel@mssm.edu
212-241-7317
Time Frame
Start Date: September 10, 2021
Estimated Completion Date: June 30, 2026
Participants
Target number of participants: 92
Treatments
Experimental: 1. Uninjured participants - Immediate and lasting effects of non-invasive paired stimulation
Participants will take part in the following to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).
Experimental: 2. Intraoperative participants - Immediate effects of paired stimulation
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Intraoperative pairing of cortical and spinal stimulation.
Experimental: 3. Intraoperative participants - Lasting effects of SCAP
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP).
Experimental: 4. Chronic cervical SCI participants - Lasting effects of non-invasive SCAP
Participants with chronic cervical SCI will take part in the following, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).
Experimental: 5. Intraoperative participants - Lasting effects of SCAP at or below myelopathic region
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region.
Authors
Ronald A Lehman, Noam Y Harel, Jason B Carmel, James R McIntosh, Michael S Virk, Daniel Riew, Chris E Mandigo
Sponsors
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Bronx Veterans Medical Research Foundation, Inc, Weill Medical College of Cornell University
Leads: Columbia University

This content was sourced from clinicaltrials.gov

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