Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2024
CompletedFirst Submitted
Initial submission to the registry
February 22, 2026
CompletedFirst Posted
Study publicly available on registry
July 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
July 8, 2026
February 1, 2026
4 years
February 22, 2026
July 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Dystonia Assessment
from Visit 2 prior to stimulation to up to 2 weeks
Resting State Functional MRI
from Visit 2 prior to stimulation to up to 1 week
Dystonia non-motor symptoms questionnaire (DNMSQuest)
Dystonia Assessment
from Visit 2 prior to stimulation to up to 2 weeks
Study Arms (3)
LIFUS - GPi
EXPERIMENTALBilateral thetaburst LIFUS stimulation to globus pallidus
LIFUS - DN
EXPERIMENTALBilateral thetaburst LIFUS stimulation to dentate nucleus
LIFUS - Sham
SHAM COMPARATORBilateral Sham LIFUS stimulation
Interventions
Eligibility Criteria
You may qualify if:
- years of age
- Confirmed diagnosis cervical dystonia
- months since last botulinum toxin injection
- Stable medications in the past month
You may not qualify if:
- Has neurological disorder other than dystonia (such as compressive neuropathy, limb trauma, epilepsy)
- Cognitive deficits leading to inability to understand study purposes and risks as well as the consent information without legal trustee
- Presence of metal implanted in body that is contraindicated in MRI
- Pregnancy
- Has a previous surgical intervention to treat CD such as lesioning or a DBS system in place
- Major systemic illness or infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Robert Chenlead
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Chen, MD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinician Scientist
Study Record Dates
First Submitted
February 22, 2026
First Posted
July 8, 2026
Study Start
November 18, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
July 8, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share