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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spasticity, Muscle; Spastic Cerebral Palsy; Spasticity as Sequela of Stroke
• Intervention / Treatment: Other: Sham; Radiation: stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uchechi Okafor, BS; Phone Number: (614) 2934876; Email: SPASMstudy@osumc.edu

Study Locations

• United States
  • Florida
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Renaissance Institute of Precision Oncology & Radiosurgery
      • Contact: Julia Pierson; Phone Number: 321-972-1102; Email: jpierson@therenaissanceinstitute.org
      • Principal Investigator: Evan Thomas, MD/PhD
      • Contact: Evan Thomas, MD/PhD; Email: ethomas@therenaissanceinstitute.org
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Wexner Medical Center
      • Sub-Investigator: Brian Dalm, MD
      • Sub-Investigator: Whitney Luke, MD
      • Sub-Investigator: Sheital Bavishi, DO
      • Sub-Investigator: Brian McMichael, MD
      • Principal Investigator: Joshua Palmer, MD
      • Contact: Uchechi Okafor; Phone Number: 614-293-4876; Email: SPASMstudy@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Treatment; No intervention but can crossover after 6 months	Other: 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.
Active Comparator: SRS Treatment	Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in spasticity-related quality of life (SQoL-6D)	Change in spasticity-related quality of life 6-dimensions instrument (SQoL-6D) over two years post-treatment, where the scale ranges from 0 (worst quality of life) to 100 (best quality of life)	2 years post treatment

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Varian Medical Systems
• Investigators: Principal Investigator: Joshua Palmer, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 30, 2023
• First Submitted That Met QC Criteria: September 30, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Cerebral Palsy; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Enzymes; Enzymes and Coenzymes; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Transferases; Alkyl and Aryl Transferases; salicylhydroxamic acid; Radiosurgery; Spermine Synthase
• Other Study ID Numbers: 2022H0425

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes