Clinical trial Recruiting at 2 sites Interventional Ages 16 and up

Treatment for muscle tightness after stroke, spinal cord injury, or cerebral palsy

Official title: A Randomized, Sham Controlled Trial of Dorsal Root Rhizotomy Stereotactic Radiosurgery Versus Standard of Care for Spasticity Associated With Stroke, Spinal Cord Injury & Cerebral Palsy

Run by Ohio State University · NCT06070233 · Data updated 2026-11-12

This study is testing a new treatment using targeted radiation to see if it can help reduce muscle tightness in people who have had a stroke, spinal cord injury, or have cerebral palsy.

More Spastic Cerebral Palsy trials

Quick facts

Study typeInterventional
Ages16 Years and up
SexAll
Enrollment22 (estimated)
SponsorOhio State University
Academic / other
Drugs / interventionsradiation
Locations2 sites (Winter Park, Florida and 1 other locations)
StatusRecruiting
StartedOctober 12, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedDecember 19, 2025
Trial IDNCT06070233 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals over 16 years old with chronic spasticity that has not responded to medical management.

Probably not a fit

Patients who are unable to lie flat for treatment or those with confirmed pregnancy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a treatment called stereotactic radiosurgery dorsal rhizotomy, which uses precise radiation beams to target specific nerves in the back to alleviate muscle tightness or spasticity. Participants are randomly assigned to receive either the actual treatment or a sham treatment that does not have therapeutic effects. Researchers will monitor the participants' muscle stiffness and any side effects following the treatment. The goal is to determine the effectiveness of this innovative approach in reducing spasticity in patients who have not responded to traditional medical management.

Why it matters

Potential benefit: If successful, this treatment could significantly improve muscle function and quality of life for patients suffering from spasticity.

How similar studies have gone: While this approach is innovative, similar studies using targeted nerve treatments have shown promise in managing spasticity.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots
* Age \> 16 (if under 18, patients parents must sign consent).

Exclusion Criteria:

* Inability to lie supine for simulation \& treatment
* Inability to visualize the target nerve on either CT or MRI imaging
* Patients with confirmed pregnancy (all women of child-bearing age with intact uterus \& ovaries will be required to undergo a pregnancy test prior to simulation)

Where it's running

  • Renaissance Institute of Precision Oncology & Radiosurgery
    Winter Park, Florida, United States
    Recruiting
  • Ohio State University Wexner Medical Center
    Columbus, Ohio, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.