Treatment for muscle tightness after stroke, spinal cord injury, or cerebral palsy
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
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Winter Park, Florida and 1 other locations) |
| Trial ID | NCT06070233 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals over 16 years old with chronic spasticity that has not responded to medical management.
Not a fit: Patients who are unable to lie flat for treatment or those with confirmed pregnancy may not benefit from this study.
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 performed: While this approach is innovative, similar studies using targeted nerve treatments have shown promise in managing spasticity.
Eligibility criteria
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 this trial is running
Winter Park, Florida and 1 other locations
- 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
- Principal investigator: Joshua Palmer, MD — Ohio State University
- Study coordinator: Uchechi Okafor, BS
- Email: SPASMstudy@osumc.edu
- Phone: (614) 2934876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.