RecruitingNot ApplicableNCT07690514

Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia


Sponsor

Robert Chen

Enrollment

48 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-blinded, randomized control study that aims to recruit 48 participants. Participants will be "randomized" into one of the study arms of the study: active stimulation to GPi, active stimulation to DN, or sham stimulation. The purpose of the study is to look into the effects of LIFUS in patients with cervical dystonia. The participation will include seven study visits, at least 24 hours apart. All study visits will take place at TWH. The first visit is a screening visit. Visits 2-6 will be on consecutive days. Visit 7 will be a week from Visit 6 or from your last day of LIFUS, whichever comes first.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called LIFUS - DN Active, a medical device called LIFUS - GPi Active, and others for people with cervical dystonia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELIFUS - GPi Active

Bilateral thetaburst LIFUS stimulation to the globus pallidus

DEVICELIFUS - DN Active

Bilateral thetaburst LIFUS stimulation to dentate nucleus

DEVICELIFUS - Sham

Bilateral sham (placebo) LIFUS stimulation


Locations(1)

Toronto Western Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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Visit

NCT07690514


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