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NCT05163639 · ClinicalTrials.gov registry record · Early Phase 1
Spinal Cord Associative Plasticity Study
A Early Phase 1 study of Cervical Spinal Cord Injury and Tetraplegia/Tetraparesis, sponsored by Columbia University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 92
- Enrollment target
- 3
- Study locations
NCT05163639 is a Early Phase 1 study of Cervical Spinal Cord Injury and Tetraplegia/Tetraparesis that is actively recruiting participants, run by Columbia University. The registered enrollment target is 92 participants, above the 17-participant average among 18 other Cervical Spinal Cord Injury trials with a reported enrollment target (441% higher). The trial reports 3 study locations across 1 state.
The verdict
NCT05163639, a Early Phase 1 study of Cervical Spinal Cord Injury and Tetraplegia/Tetraparesis, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 92 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Non-invasive pairing of cortical and spinal stimulation
- PROCEDURE Intraoperative pairing of cortical and spinal stimulation
- PROCEDURE Non-invasive repeated pairing of cortical and spinal stimulation (SCAP)
- PROCEDURE Intraoperative repeated pairing of cortical and spinal stimulation (SCAP)
- PROCEDURE Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region
Study Locations (3)
New York
- Bronx Veterans Medical Research Foundation, Inc - New York
- Columbia University Irving Medical Center - New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2021-09-10 |
| Est. Completion | 2026-06-30 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05163639
The ClinicalTrials.gov registry entry for NCT05163639 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 17-participant average among 18 other Cervical Spinal Cord Injury trials with a reported enrollment target (441% higher). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Cervical Spinal Cord Injury appearing as the primary indexed condition, and to 5 interventions - of which Non-invasive pairing of cortical and spinal stimulation is the first listed.
NCT05163639 reports 3 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT05163639 about?
NCT05163639 is a clinical study titled "Spinal Cord Associative Plasticity Study". 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 th...
What is the current status of trial NCT05163639?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 92 participants. The study started on 2021-09-10. Estimated completion is 2026-06-30.
What conditions does trial NCT05163639 study?
This clinical trial studies the following conditions: Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Cervical Myelopathy.
What interventions are being tested in trial NCT05163639?
The interventions under investigation include: Non-invasive pairing of cortical and spinal stimulation (PROCEDURE), Intraoperative pairing of cortical and spinal stimulation (PROCEDURE), Non-invasive repeated pairing of cortical and spinal stimulation (SCAP) (PROCEDURE), Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) (PROCEDURE), Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region (PROCEDURE).
Who is sponsoring clinical trial NCT05163639?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05163639 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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