Recruiting

Stereotactic Radiosurgery

Sponsor:

Ohio State University

Code:

NCT06070233

Conditions

Spasticity as Sequela of Stroke

Spastic Cerebral Palsy

Spasticity, Muscle

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation

Sham

Study Details

Brief 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.

Conditions

Spasticity as Sequela of Stroke

Spastic Cerebral Palsy

Spasticity, Muscle

Study ID

NCT06070233

Start date

Oct 12, 2023

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

22 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham Treatment

No intervention but can crossover after 6 months

active comparator: SRS Treatment

Interventions

stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation

Patients will be simulated in the supine position in an immobilization apparatus deemed by the treating physician to be appropriate for the patient being able to comfortably maintain position for the duration of treatment. All patients will be simulated and treated using free breathing. Prescription dose is 50 Gy delivered in a single fraction to the target volume, prescribed to whatever isodose line produces optimal falloff (but not less than a 50% isodose line; dmax <100Gy) .

All radiosurgery treatment will utilize the Varian Edge, Varian TrueBeam STx, or CyberKnife system

Sham

Patients will be simulated in the supine position in an immobilization apparatus deemed by the treating physician to be appropriate for the patient being able to comfortably maintain position for the duration of treatment. All patients will be simulated and treated using free breathing.

Primary outcome measure

  • Change in Modified Ashworth Scale [ Time Frame: 6 months post treatment ]

Central Contacts and Locations

Central contacts

Uchechi Okafor, BS

(614) 2934876SPASMstudy@osumc.edu

Locations

Renaissance Institute of Precision Oncology & Radiosurgery

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Julia Pierson

321-972-1102jpierson@therenaissanceinstitute.org

Evan Thomas, MD/PhD

ethomas@therenaissanceinstitute.org

Principal Investigator:

Evan Thomas, MD/PhD

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Uchechi Okafor

614-293-4876SPASMstudy@osumc.edu

Principal Investigator:

Joshua Palmer, MD

More Information

Sponsor

Ohio State University

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-12-19.