Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy

Spasticity
Online since 27 December 2023, updated 65 days ago

About this trial

This trial is enrolling 22 individuals with spasticity associated with spinal cord injury, stroke, and cerebral palsy to test the effect of a procedure called stereotactic radiosurgery dorsal rhizotomy. It uses a precisely focused form of radiation therapy delivered in a single session to the sensory nerve roots in the back with the intent of reducing the function of nerves that contribute to spasticity. Similar to radiation therapy used to treat tumors, this intervention is delivered to the treatment area from outside of the body, with specific targeting and dosing appropriate for this neurological application. If included, participants will receive either the active intervention or a sham (fake) intervention. Final testing of spasticity and quality of life will be performed after 2 years. Participants who receive the sham treatment will be eligible to receive the active intervention after 6 months.

Included participants

Gender
All
Age
≥ 16 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    Have chronic severe spaticity refractory to medical management
    Be at least 16 years of age

    What’s involved

    Type

    Observational

    Details

    - participants will receive either the 'active' intervention or the 'sham' intervention. - The active intervention is called stereotactic radiosurgery dorsal rhizotomy, which uses external radiation beams in a single session to precisely target certain nerves in the back to reduce spasticity and lessen related muscle stiffness. - Final testing of spasticity and quality of life will be performed after 2 years. - Participants who receive the 'sham' intervention will be eligible to receive the 'active' intervention after 6 months.

    Potential benefits

    Main benefits

    Spasticity

    Additional benefits

    General health

    Mental health

    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
    • 12 Oct 2023
    • Organisation
    • Ohio State University
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 12 Oct 2023
    • Organisation
    • Ohio State University

    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