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RECRUITING
NCT07690514
NA

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

Sponsor: Robert Chen

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-11-18

Completion Date

2029-12

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DEVICE

LIFUS - GPi Active

Bilateral thetaburst LIFUS stimulation to the globus pallidus

DEVICE

LIFUS - DN Active

Bilateral thetaburst LIFUS stimulation to dentate nucleus

DEVICE

LIFUS - Sham

Bilateral sham (placebo) LIFUS stimulation

Locations (1)

Toronto Western Hospital

Toronto, Ontario, Canada