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

Официальное название

A Randomized, Sham Controlled Trial of Dorsal Root Rhizotomy Stereotactic Radiosurgery Versus Standard of Care for Spasticity Associated With Stroke, Spinal Cord Injury & Cerebral Palsy

Обзор

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.

Вмешательства

• Лучевая терапия stereotactic radiosurgery (SRS) dorsal root rhizotomy radiomodulation
  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 radiosurger
• Другое Sham
  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.

Первичные конечные точки

• Change in Modified Ashworth Scale [Срок оценки: 6 months post treatment]

Вторичные конечные точки (1)

• Change in spasticity-related quality of life (SQoL-6D) [Срок оценки: 2 years post treatment]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Renaissance Institute of Precision Oncology & Radiosurgery — Winter Park
• Ohio State University Wexner Medical Center — Columbus

Идентификаторы

NCT: NCT06070233 · 2022H0425

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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