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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post treatment
Awards & highlights
SPASM Trial 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.Check my eligibility
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.See study design
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.
SPASM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My severe muscle stiffness hasn't improved with medication.
SPASM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Modified Ashworth Scale
Secondary outcome measures
Change in spasticity-related quality of life (SQoL-6D)
SPASM 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
830 Previous Clinical Trials
505,598 Total Patients Enrolled
5 Trials studying Cerebral Palsy
338 Patients Enrolled for Cerebral Palsy
Varian Medical SystemsIndustry Sponsor
59 Previous Clinical Trials
3,757 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are potential subjects currently being accepted for this investigation?
"According to the information sourced from clinicaltrials.gov, this particular medical study is not presently enrolling patients. Posting initially occurring on October 11th 2023 and most recently updated September 30th 2023; however, there are over one thousand other trials actively seeking participants at present."
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