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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorOhio State University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation
  • Sham

Treatment groups

22 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ohio State University

Lead sponsor

Varian Medical Systems

Collaborator