Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia
NCT07690514 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-07-08
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.
Conditions
- Cervical Dystonia
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
Sponsors & Collaborators
-
Robert Chen
lead OTHER
Principal Investigators
-
Robert Chen, MD · University Health Network, Toronto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-18
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
Countries
- Canada
Study Locations
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