Rebuilding Inter-limb Transfer in Cervical SCI

Technology
General health
Online since 5 October 2024, updated 76 days ago

About this trial

This phase I trial is enrolling 17 participants with chronic cervical spinal cord injury to test the effect of paired corticospinal-motor neuronal stimulation (PCMS) combined with exercise on arm and hand function. PCMS involves the simultaneous or paired delivery of transcranial magnetic stimulation (TMS) to the brain and peripheral nerve stimulation (PNS) to the muscles. TMS is a non-invasive technique which uses a magnetic field to stimulate the brain. PNS is a non-invasive technique that uses electrical impulses to stimulate the nerves. Investigators want to see if motor skills acquired in one limb can transfer to the opposite, untrained limb. If included, participants will receive the following interventions in a random order: PCMS alone; PCMS combined with exercise on the opposite limb; and a sham stimulation combined with exercise on the opposite limb. Final testing of arm and hand function will be performed 4-6 hours after the session.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C4 - C8
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
    Healthy volunteers
    Yes
    C4-C8
    Additionally, participants must
    NOT have a history of other neurological conditions such as stroke, Parkinson's, and traumatic brain injury (TBI)
    NOT have a pacemaker, metal in the skull, seizure history.

    What’s involved

    Type

    Technology

    Details

    - Participants will receive the following interventions in a random order: PCMS alone, PCMS combined with exercise on the opposite limb, and a sham stimulation combined with exercise on the opposite limb. - Paired corticospinal-motor neuronal stimulation (PCMS) involves the simultaneous or paired delivery of transcranial magnetic stimulation (TMS) to the brain and peripheral nerve stimulation (PNS) to the muscles. - TMS is a non-invasive technique which uses a magnetic field to stimulate the brain. A coil (held over the head) delivers the magnetic stimulation that activates the central nervous system. - PNS is a non-invasive technique that uses electrical impulses to stimulate the nerves. Electrodes (placed on the skin) deliver the stimulation that activates the peripheral nervous system. - Final testing of arm and hand function will be performed 4-6 hours after the session.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Feb 2024
    • Organisation
    • The Cleveland Clinic
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Feb 2024
    • Organisation
    • The Cleveland Clinic

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more