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

NCT ID: NCT06070233

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham Treatment

No intervention but can crossover after 6 months

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: 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.

SRS Treatment

Group Type: ACTIVE_COMPARATOR

stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation

Intervention Type: 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

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

Intervention Type: RADIATION

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Varian Medical Systems

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Joshua Palmer

Professor, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Renaissance Institute of Precision Oncology & Radiosurgery

Winter Park, Florida, United States

Site Status: RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

Italy; United States

Central Contacts

Uchechi Okafor, BS

Role: CONTACT

Phone: (614) 2934876

Email: SPASMstudy@osumc.edu

Facility Contacts

Julia Pierson

Role: primary

Evan Thomas, MD/PhD

Role: backup

Uchechi Okafor

Role: primary

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2022H0425

Identifier Type: -

Identifier Source: org_study_id