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

Launched by OHIO STATE UNIVERSITY · Sep 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people who have tight muscles, a condition known as spasticity, which can happen after a stroke, in those with spastic cerebral palsy, or from spinal cord injuries. The treatment being tested is called "stereotactic radiosurgery dorsal rhizotomy." It uses focused beams of radiation to target specific nerves in the back to help relax the muscles. Participants in the study will be randomly divided into two groups: one will receive the actual treatment, while the other will receive a "sham" treatment that does not have any active effect. This design helps ensure the study's results are accurate.

To be eligible for the trial, participants must be over 16 years old and have spasticity that hasn’t improved with other treatments. They should be able to lie down comfortably during the procedure and the target nerves must be visible in imaging tests. Women of child-bearing age will need to take a pregnancy test before joining the study. After receiving their treatment, participants will be monitored to see if their muscle stiffness improves and to check for any side effects. Additionally, those who receive the sham treatment will have the chance to get the real treatment after six months.

Gender

ALL

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)