SPASM: Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in Modified Ashworth Scale [6 months post treatment]
Change in the 6-month post-treatment Modified Ashworth Scale (MAS) measure of spasticity, which ranges from 0 (no symptoms) to 4 (worst symptoms)
Secondary Outcome Measures
- Change in spasticity-related quality of life (SQoL-6D) [2 years post treatment]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots
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Age > 16 (if under 18, patients parents must sign consent).
Exclusion Criteria:
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Inability to lie supine for simulation & treatment
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Inability to visualize the target nerve on either CT or MRI imaging
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ohio State University Wexner Medical Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Ohio State University
- Varian Medical Systems
Investigators
- Principal Investigator: Evan Thomas, MD/PhD, The Ohio State University Wexner Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 2022H0425