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

ConditionsSpasticity as Sequela of Stroke Spastic Cerebral Palsy Spasticity, Muscle

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation
Radiation
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
Sham
Other intervention
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.

Treatment groups

22 Participants

are divided into 2 treatment groups

Group A: Sham TreatmentSham comparator 1 intervention

Group B: SRS TreatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

6 months post treatment

Secondary outcomes

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)

Time frame

2 years post treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Varian Medical Systems

Collaborator

Source ClinicalTrials.gov

Apply now