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Radiation

Radiosurgery for Spasticity (SPASM Trial)

N/A
Recruiting
Led By Evan Thomas, MD/PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic spasticity refractory to medical management or in a patient who cannot receive appropriate medical management mediated by one or more spinal nerve roots
Must not have
Inability to lie supine for simulation & treatment
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post treatment
Awards & highlights

Summary

This trial tests a new treatment for people with tight muscles, using accurate radiation beams to target nerves. Results will be compared between people who get the real treatment & those who receive a "sham" treatment, to see if the treatment works and if there are side effects.

Who is the study for?
This trial is for individuals over 16 years old with chronic spasticity from conditions like stroke, SCI, or cerebral palsy that doesn't improve with medication. If under 18, parental consent is needed. It's not for those who can't lie on their back for the procedure, if the target nerve isn't visible on scans, or if pregnant.
What is being tested?
The study tests a treatment called stereotactic radiosurgery dorsal rhizotomy which aims to reduce muscle stiffness by targeting nerves with radiation. Participants are randomly assigned to receive either this real treatment or a sham (fake) procedure to compare outcomes.
What are the potential side effects?
Potential side effects aren't specified but may include typical risks associated with radiation therapy such as localized skin irritation and fatigue. The precise nature of SRS minimizes widespread side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My severe muscle stiffness hasn't improved with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot lie on my back for treatments.
Select...
I am not pregnant or have confirmed I am not pregnant through a test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Modified Ashworth Scale
Secondary study objectives
Change in spasticity-related quality of life (SQoL-6D)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SRS TreatmentActive Control1 Intervention
Group II: Sham TreatmentPlacebo Group1 Intervention
No intervention but can crossover after 6 months

Find a Location

Who is running the clinical trial?

Centro Diagnostico Milano, Co-PI: Pantaleo Romanelli, MDUNKNOWN
Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,743 Total Patients Enrolled
7 Trials studying Cerebral Palsy
360 Patients Enrolled for Cerebral Palsy
Varian Medical SystemsIndustry Sponsor
61 Previous Clinical Trials
3,622 Total Patients Enrolled
~15 spots leftby Dec 2026
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