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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A scientific study is being done to test a special treatment for people who have spasticity or tight muscles. This treatment is called stereotactic radiosurgery dorsal rhizotomy. It uses very accurate beams of radiation to target certain nerves in the back to help loosen up the muscles. In this study, people are put into two groups by chance: one group gets the real treatment, and the other group gets a fake treatment that doesn't do anything. This fake treatment is called a sham. Doing this helps make sure the study is fair and the results are true. After the people in the study get their treatment, the researchers will watch and see how they do. They will check if their muscles are less stiff and if they have any side effects. By looking at the results from both groups, the researchers can find out if the special treatment really helps people with spasticity. Patients who got the fake treatment will be eligible to receive the real treatment after 6 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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).

Locations
United States
Florida
Renaissance Institute of Precision Oncology & Radiosurgery
NOT_YET_RECRUITING
Winter Park
Ohio
Ohio State University Wexner Medical Center
RECRUITING
Columbus
Contact Information
Primary
Uchechi Okafor, BS
SPASMstudy@osumc.edu
(614) 2934876
Time Frame
Start Date: 2023-10-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 22
Treatments
Sham_comparator: Sham Treatment
No intervention but can crossover after 6 months
Active_comparator: SRS Treatment
Sponsors
Collaborators: Varian Medical Systems
Leads: Ohio State University

This content was sourced from clinicaltrials.gov