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NCT06070233Recruiting

Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & 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

Source: ClinicalTrials.gov · Last updated 19 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
22 (estimated)
First submitted
30 Sept 2023
Start date
12 Oct 2023
Primary completion date
31 Dec 2026
Lead sponsor
Ohio State University
Diseases
Stroke
NCT number
NCT06070233

What you commit to

  • Study type: Interventional
  • Planned participants: 22
  • From 12 Oct 2023 to the primary completion date, 31 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other

  • Inability to lie supine for simulation \& treatment
  • Inability to visualize the target nerve on either CT or MRI imaging

Who the study is looking for

  • 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).

Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ohio State University Wexner Medical Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Renaissance Institute of Precision Oncology & Radiosurgery
Coordinator of this site? Confirm its status
Winter ParkUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.