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

July 5, 2026 updated by: Robert Chen
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomly assigned to one of three conditions (n =12 per condition): 1) bilateral tbLIFUS of the GPi, 2) bilateral tbLIFUS of the DN, and 3) bilateral sham tbLIFUS. Study participants will be randomized in a 1:1:1 fashion. In each group, the patients will receive tbLIFUS for five consecutive days. tbLIFUS will consist of two 120 s stimulation (one for each hemisphere, separated by 1 min). Visit 1 will consist of an anatomical MRI scan for each subject to allow accurate targeting of the GPi and DN, and for modelling the ultrasound distribution. Visit 2 will consist of baseline clinical assessments followed by pre-LIFUS rsfMRI. Immediately after, patients will receive tbLIFUS. Visits 3-5 will consist of tbLIFUS only. In Visit 6 (day 5 of stimulation), patients will receive tbLIFUS followed by rsfMRI and clinical assessments. In Visit 7, patients will undergo clinical assessments one week (+/- 3 days) after the last stimulation session in Visit 6. All patients and evaluators will be blinded to the stimulation condition. Visits 2-6 (stimulation days) will be conducted on five consecutive days. Outcome variables will be functional connectivity using rsfMRI, dystonia assessment (TWSTRS and DNMSQuest), cerebellar function assessment (Scale for the Assessment and Rating of Ataxia, SARA), head angle, tremor measurements, and phasic neck movements. SARA will be used in all conditions but will be primarily used to ensure that our protocol does not cause cerebellar dysfunction due to tbLIFUS of the DN. Tremor and phasic neck movements will be quantified with a three-axis accelerometer and neck angle will be measured using a goniometer. All clinical assessments will be video recorded and scored by two blinded movement disorders neurologists.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital
        • Contact:
        • Principal Investigator:
          • Robert Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 - 90 years of age
  • Confirmed diagnosis cervical dystonia
  • 3 months since last botulinum toxin injection
  • Stable medications in the past month

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFUS - GPi
Bilateral thetaburst LIFUS stimulation to globus pallidus
Device: LIFUS - GPi Active
Bilateral thetaburst LIFUS stimulation to the globus pallidus
Experimental: LIFUS - DN
Bilateral thetaburst LIFUS stimulation to dentate nucleus
Device: LIFUS - DN Active
Bilateral thetaburst LIFUS stimulation to dentate nucleus
Sham Comparator: LIFUS - Sham
Bilateral Sham LIFUS stimulation
Device: LIFUS - Sham
Bilateral sham (placebo) LIFUS stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Time Frame: from Visit 2 prior to stimulation to up to 2 weeks
Dystonia Assessment
from Visit 2 prior to stimulation to up to 2 weeks
Resting State Functional MRI
Time Frame: from Visit 2 prior to stimulation to up to 1 week
from Visit 2 prior to stimulation to up to 1 week
Dystonia non-motor symptoms questionnaire (DNMSQuest)
Time Frame: from Visit 2 prior to stimulation to up to 2 weeks
Dystonia Assessment
from Visit 2 prior to stimulation to up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Chen

Investigators

  • Principal Investigator: Robert Chen, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

July 5, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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