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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Radiation: stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation
* Other: Sham


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Treatment<br>No intervention but can crossover after 6 months | Other: Sham<br>* 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.<br>|
| Active Comparator: SRS Treatment<br> | Radiation: stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation<br>* 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<br>|

What is the study measuring?
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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 |