Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
NCT06070233

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

Led by Ohio State University · Updated on 2025-12-19

22

Participants Needed

2

Research Sites

168 weeks

Total Duration

On this page

Sponsors

O

Ohio State University

Lead Sponsor

V

Varian Medical Systems

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic spasticity not improved by medical treatments or in patients unable to receive proper medical management affecting one or more spinal nerve roots
  • Age 16 years or older (parental consent required if under 18)
Not Eligible

You will not qualify if you...

  • Unable to lie on back for simulation and treatment
  • Target nerve not visible on CT or MRI imaging
  • Confirmed pregnancy (women of child-bearing age must have pregnancy test before simulation)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Renaissance Institute of Precision Oncology & Radiosurgery

Winter Park, Florida, United States, 32789

Actively Recruiting

2

Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

U

Uchechi Okafor, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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