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

Part of paid clinical trials in Winter Park, Florida.

Sponsor
Ohio State University
Study ID
NCT06070233
Status
Recruiting
Apply to this trial

Conditions

  • Spastic Cerebral Palsy
  • Spasticity as Sequela of Stroke
  • Spasticity, Muscle

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

Start date
Oct 12, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham Treatment
    No intervention but can crossover after 6 months
  • Active Comparator: SRS Treatment

Primary Outcome Measure

Change in Modified Ashworth Scale [ Time Frame: 6 months post treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Renaissance Institute of Precision Oncology & RadiosurgeryWinter ParkFlorida32789
Julia Pierson
[email protected]
321-972-1102
Evan Thomas, MD/PhD
[email protected]
Evan Thomas, MD/PhD (PRINCIPAL_INVESTIGATOR)
Ohio State University Wexner Medical CenterColumbusOhio43210
Uchechi Okafor
[email protected]
614-293-4876
Brian Dalm, MD (SUB_INVESTIGATOR)
Whitney Luke, MD (SUB_INVESTIGATOR)
Sheital Bavishi, DO (SUB_INVESTIGATOR)
Brian McMichael, MD (SUB_INVESTIGATOR)
Joshua Palmer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winter Park, FL

By research site
Renaissance Institute of Precision Oncology & Radiosurgery· Winter Park, FLOhio State University Wexner Medical Center· Columbus, OH

Related Studies