Study of Stereotactic Radiosurgery Dorsal Rhizotomy for Treating Spasticity After Stroke, Spinal Cord Injury, or Cerebral Palsy

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.

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