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

Spasticity, Muscle Clinical Trial

— SPASM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070233
• Other study ID #: 2022H0425
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Destiny West, BS
• Phone: (614) 366-7822
• Email: SPASMstudy[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

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.

Locations

Country	Name	City	State
Italy	Centro Diagnostico Italiano	Milano
United States	Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	Centro Diagnostico Milano, Co-PI: Pantaleo Romanelli, MD, Varian Medical Systems

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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