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

NCT06070233 | Recruiting FDA Device

• 1 other identifier: 2022H0425
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (1)

• Change in Modified Ashworth Scale

  Change in the 6-month post-treatment Modified Ashworth Scale (MAS) measure of spasticity, which ranges from 0 (no symptoms) to 4 (worst symptoms)

  6 months post treatment

Secondary Outcomes (1)

• Change in spasticity-related quality of life (SQoL-6D)

  2 years post treatment

Study Arms (2)

Sham Treatment

SHAM COMPARATOR

No intervention but can crossover after 6 months

Other: Sham

SRS Treatment

ACTIVE COMPARATOR

Radiation: stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation

Interventions

stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation RADIATION

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

SRS Treatment

Sham OTHER

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.

Sham Treatment

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University: lead
• Varian Medical Systems: collaborator

Study Sites (2)

Renaissance Institute of Precision Oncology & Radiosurgery

Winter Park, Florida, 32789, United States

RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Radiosurgery; Spermine Synthase; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Joshua Palmer, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uchechi Okafor, BS

CONTACT

(614) 2934876; SPASMstudy@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiation Oncology

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 6, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (2)