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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: Recruiting Early Phase 1 study of Cervical Spinal Cord Injury and Tetraplegia/Tetraparesis, sponsored by Columbia University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Size of hand muscle response will be measured in response to brain and spinal cord stimulation timed to converge in the spinal cord. This value will be normalized to the muscle response for brain only stimulation. This applies to Arms 1-2.

Conditions Studied

Cervical Spinal Cord Injury Tetraplegia/Tetraparesis Cervical Myelopathy

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

FieldValue
Enrollment Target 92 participants
Start Date 2021-09-10
Est. Completion 2026-06-30
Phase Early Phase 1
Columbia University

958 total trials

What NCT05163639 shows while recruiting

NCT05163639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, above the 17-participant average among 18 other Cervical Spinal Cord Injury trials with a reported enrollment target (441% higher).

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 a single indexed study location in 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.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05163639's enrollment target sits among peer trials

92 1st of 18 higher than 18 of 18 other Cervical Spinal Cord Injury trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cervical Spinal Cord Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05163639

Source: ClinicalTrials.gov NCT05163639, the US trial registry maintained by the National Library of Medicine. NCT05163639 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.