A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients

Technology
General health
Online since 15 March 2025, updated 262 days ago

About this trial

This trial is enrolling 25 individuals with spinal cord injury to test the effect of different stimulation methods on specific muscle groups. If included, participants will undergo either: i) transcranial magnetic stimulation (TMS) to activate the brain; ii) electrical spinal cord stimulation (SCS) to activate the spinal cord; iii) functional electrical stimulation (FES) to activate arms, legs) and trunk; or iv) sham TMS. 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 to activate the central nervous system. SCS is a technique for stimulating the spinal cord via surface electrodes to modify spinal cord function. FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. Final testing of muscle activation and response will be performed after 2 months.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    Yes
    C1-T10
    Additionally, participants must
    NOT have metal implants near stimulation sites (e.g., head or spine), implantable devices (e.g., cochlear implants, neurostimulators such as DBS or VNS), or cardiac devices (e.g., pacemakers or intracardiac lines)
    NOT have a traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function
    NOT have a history of epilepsy, convulsion or seizures

    What’s involved

    Type

    Technology

    Details

    - Participants will undergo either i) transcranial magnetic stimulation (TMS) to activate the brain, ii) electrical spinal cord stimulation (SCS) to activate the spinal cord, iii) functional electrical stimulation (FES) to activate the upper limb (arms), lower limb (legs) and trunk (stomach) muscles or iv) sham TMS. - They will attend at least 9 sessions over 2 months, each lasting 2-3 hours. - 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. - SCS is a technique for stimulating the spinal cord via surface stimulation to modify spinal cord function. - FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. - Final testing of muscle activation and response will be performed after 2 months.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Standing/walking/mobility

    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
    • 4 Nov 2024
    • Organisation
    • University of Miami
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 4 Nov 2024
    • Organisation
    • University of Miami

    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