NCT06070233 Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
| NCT ID | NCT06070233 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Spasticity as Sequela of Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2023-10-12 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2023-10-12 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Joshua Palmer, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06070233 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Spasticity as Sequela of Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06070233 currently recruiting?
Yes, NCT06070233 is actively recruiting participants. Contact the research team at SPASMstudy@osumc.edu for enrollment information.
Where is the NCT06070233 trial being conducted?
This trial is being conducted at Winter Park, United States, Columbus, United States.
Who is sponsoring the NCT06070233 clinical trial?
NCT06070233 is sponsored by Ohio State University. The principal investigator is Joshua Palmer, MD at Ohio State University. The trial plans to enroll 22 participants.
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