Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation, Sham.
- Who it may be relevant to
- Registry conditions: Spasticity as Sequela of Stroke, Spastic Cerebral Palsy, Spasticity, Muscle. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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 radiosurger - 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.
Primary outcome measures
- Change in Modified Ashworth Scale [Time frame: 6 months post treatment]
Secondary outcome measures (1)
- Change in spasticity-related quality of life (SQoL-6D) [Time frame: 2 years post treatment]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Renaissance Institute of Precision Oncology & Radiosurgery — Winter Park
- Ohio State University Wexner Medical Center — Columbus
Identifiers
NCT: NCT06070233 · 2022H0425