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RECRUITING Early Phase 1

Spinal Cord Associative Plasticity Study

NCT05163639 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Columbia University

875 total trials

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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. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 875 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05163639 reports 3 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05163639?

This trial is sponsored by Columbia University, which has 875 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial