Cervical DystoniaNCT07690514
Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia
A study testing LIFUS - GPi Active and LIFUS - DN Active in people with Cervical Dystonia, run by Robert Chen at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- LIFUS - GPi Active and LIFUS - DN Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 18 Nov 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 90 years of age
- Confirmed diagnosis cervical dystonia
- 3 months since last botulinum toxin injection
- Stable medications in the past month
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Julian Kwok, 416-603-5800 ext. 2708, julian.kwok@uhn.ca
Robert Chen, MD
About this study
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.
Read the 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.
- Conditions
- Cervical Dystonia
- Being tested
- LIFUS - GPi Active, LIFUS - DN Active, LIFUS - Sham
- Keywords
- Cervical Dystonia
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFUS - GPi ActiveDevice
Bilateral thetaburst LIFUS stimulation to the globus pallidus
LIFUS - DN ActiveDevice
Bilateral thetaburst LIFUS stimulation to dentate nucleus
LIFUS - ShamDevice
Bilateral sham (placebo) LIFUS stimulation
| Study group | Role | What they receive |
|---|---|---|
| LIFUS - GPi | Experimental | Bilateral thetaburst LIFUS stimulation to globus pallidus Receives: Device: LIFUS - GPi Active |
| LIFUS - DN | Experimental | Bilateral thetaburst LIFUS stimulation to dentate nucleus Receives: Device: LIFUS - DN Active |
| LIFUS - Sham | Sham comparator | Bilateral Sham LIFUS stimulation Receives: Device: LIFUS - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Dystonia Assessment
Measured: from Visit 2 prior to stimulation to up to 2 weeks
Resting State Functional MRI
Measured: from Visit 2 prior to stimulation to up to 1 week
Dystonia non-motor symptoms questionnaire (DNMSQuest)
Dystonia Assessment
Measured: from Visit 2 prior to stimulation to up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start18 Nov 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Chen, University Health Network, Toronto
- Investigators
- Robert Chen, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690514
- Sponsor's protocol ID
- 23-5741
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia
- ClinicalTrials.gov ID
- NCT07690514
- Acronym / sponsor ID
- 23-5741
- Conditions
- Cervical Dystonia
- Keywords
- Cervical Dystonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Robert ChenUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LIFUS - GPi | Experimental | Device: LIFUS - GPi ActiveBilateral thetaburst LIFUS stimulation to globus pallidus |
| LIFUS - DN | Experimental | Device: LIFUS - DN ActiveBilateral thetaburst LIFUS stimulation to dentate nucleus |
| LIFUS - Sham | Sham comparator | Device: LIFUS - ShamBilateral Sham LIFUS stimulation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 90 years of age
- Confirmed diagnosis cervical dystonia
- 3 months since last botulinum toxin injection
- Stable medications in the past month
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIFUS - GPi ActiveBilateral thetaburst LIFUS stimulation to the globus pallidus | Device | LIFUS - GPi |
| LIFUS - DN ActiveBilateral thetaburst LIFUS stimulation to dentate nucleus | Device | LIFUS - DN |
| LIFUS - ShamBilateral sham (placebo) LIFUS stimulation | Device | LIFUS - Sham |
Primary outcome
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Time frame: from Visit 2 prior to stimulation to up to 2 weeks
Dystonia Assessment
Resting State Functional MRI
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Chen, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFUS - GPi Active and LIFUS - DN Active in people with Cervical Dystonia, run by Robert Chen at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Francois Nankoo, PhD (416-603-5792, jean-francois.nankoo@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (time frame: from Visit 2 prior to stimulation to up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.