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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06070233
Other study ID # 2022H0425
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 12, 2023
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source Ohio State University
Contact Destiny West, BS
Phone (614) 366-7822
Email SPASMstudy@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 22
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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)

Study Design


Intervention

Radiation:
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 radiosurgery treatment will utilize the Varian Edge, Varian TrueBeam STx, or CyberKnife system
Other:
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.

Locations

Country Name City State
Italy Centro Diagnostico Italiano Milano
United States Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (3)

Lead Sponsor Collaborator
Ohio State University Centro Diagnostico Milano, Co-PI: Pantaleo Romanelli, MD, Varian Medical Systems

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Modified Ashworth Scale Change in the 6-month post-treatment Modified Ashworth Scale (MAS) measure of spasticity, which ranges from 0 (no symptoms) to 4 (worst symptoms) 6 months post treatment
Secondary Change in spasticity-related quality of life (SQoL-6D) 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) 2 years post treatment
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