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

Description

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

Spasticity as Sequela of Stroke, Spastic Cerebral Palsy, Spasticity, Muscle

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Spasticity as Sequela of Stroke
Intervention / Treatment

-

Contacts and Locations

Columbus

Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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)

Ages Eligible for Study

16 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Evan Thomas, MD/PhD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

2026-12-31