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NCT Number: NCT06070233

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

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.

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Key information

Conditions

Spasticity as Sequela of Stroke Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spastic Cerebral Palsy Spasticity, Muscle

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renaissance Institute of Precision Oncology & Radiosurgery, Winter Park, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change in Modified Ashworth Scale

    Time frame: 6 months post treatment

    Change in the 6-month post-treatment Modified Ashworth Scale (MAS) measure of spasticity, which ranges from 0 (no symptoms) to 4 (worst symptoms)

Secondary outcomes

  1. Change in spasticity-related quality of life (SQoL-6D)

    Time frame: 2 years post treatment

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Uchechi Okafor, BS

CONTACT

[email protected]

(614) 2934876

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Varian Medical Systems

Registry information

Official study title

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

Acronym: SPASM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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