Actively Recruiting
Randomized, Sham Controlled Trial of Dorsal Root Rhizotomy Stereotactic Radiosurgery Versus Standard Care for Spasticity Related to Stroke, Spinal Cord Injury & Cerebral Palsy
Led by Ohio State University · Updated on 2025-12-19
22
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a special treatment called stereotactic radiosurgery dorsal rhizotomy for people who have spasticity or tight muscles caused by stroke, spinal cord injury, or cerebral palsy. The study aims to see if this precise radiation treatment targeting certain nerves in the back can help loosen muscles and improve symptoms. The trial is randomized and includes a comparison with a sham treatment to ensure fair and accurate results. Participants will be randomly assigned to receive either the real stereotactic radiosurgery treatment or a sham procedure that mimics the treatment without delivering radiation. The radiosurgery delivers a single high dose of radiation (50 Gy) using advanced systems such as Varian Edge, Varian TrueBeam STx, or CyberKnife, while the sham group undergoes similar positioning but no actual radiation. After 6 months, those who received the sham treatment may have the option to crossover and receive the real treatment. During the study, participants will be monitored for changes in muscle stiffness using the Modified Ashworth Scale at 6 months after treatment. Researchers will also assess quality of life related to spasticity up to 2 years post treatment. The study involves careful imaging and positioning for treatment delivery, and safety is monitored including pregnancy testing for women of child-bearing age. The total duration of participation includes initial treatment and long-term follow-up assessments.
CONDITIONS
Brief Title
Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic spasticity that does not improve with medical management or cannot be treated medically due to spinal nerve root issues
- Age 16 years or older (if under 18, parental consent required)
You will not qualify if you...
- Unable to lie flat on back for simulation and treatment
- Target nerve not visible on CT or MRI scans
- Confirmed pregnancy or positive pregnancy test if woman is of child-bearing age with intact uterus and ovaries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with crossover option after 6 months
Participants receive either stereotactic radiosurgery dorsal root rhizotomy radiomodulation or sham treatment. Those in the sham group may crossover to active treatment after 6 months.
1 treatment visit (in-person)
Duration - Up to 2 years post treatment
Participants are monitored to assess changes in spasticity and quality of life after treatment.
Follow-up visits at 6 months and periodically up to 2 years
Trial Site Locations
Total: 2 locations
1
Renaissance Institute of Precision Oncology & Radiosurgery
Winter Park, Florida, United States, 32789
Actively Recruiting
2
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
U
Uchechi Okafor, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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