Targeted Focused Ultrasound for Cervical Dystonia
Official title: Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia
Run by University Health Network, Toronto · NCT07690514 · Data updated 2026-11-12
This trial tests whether applying theta burst focused ultrasound to brain regions GPi or DN, or a sham, can help people with cervical dystonia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | November 18, 2024 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT07690514 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–90 with a confirmed cervical dystonia, at least 3 months since last botulinum toxin, and stable medications in the past month.
✕Probably not a fit
Individuals with other neurological conditions, recent brain implants, pregnancy, or major systemic illness may not benefit and could be excluded or experience risks without expected benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, single-blind trial enrolling 48 adults with cervical dystonia to receive bilateral tbLIFUS to either GPi, DN, or a sham treatment over five consecutive days. Participants undergo MRI targeting, baseline assessments, and repeated clinical and imaging measures, including rsfMRI, TWSTRS, DNMSQuest, SARA, and neck movement metrics. The study evaluates changes in brain connectivity and dystonia-related symptoms to see if targeted ultrasound modulates neural circuits involved in dystonia. All participants and investigators are blinded to treatment assignment. The study is conducted at Toronto Western Hospital in Ontario, with assessments spanning screening, stimulation days, and a follow-up visit one week after treatment.
Why it matters
Potential benefit: If successful, participants may experience improvements in dystonia symptoms and related motor function.
How similar studies have gone: Previous work in focused ultrasound for movement disorders supports feasibility and potential benefit, but this exact bilateral tbLIFUS approach for cervical dystonia is investigational.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Toronto Western Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Robert Chen, MD — University Health Network, Toronto
- Study coordinator: Jean-Francois Nankoo, PhD
- Email: jean-francois.nankoo@uhn.ca
- Phone: 416-603-5792
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Noninvasive brain stimulation for cervical dystonia using continuous theta-burst in a sham-controlled trial
This study tests whether delivering continuous theta-burst stimulation to the brain can reduce neck dystonia symptoms compared with sham stimulation.
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Vibration to improve head posture in cervical dystonia
This trial will test whether stronger vibration applied to the neck muscles helps correct abnormal head posture in people with cervical dystonia.
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Adding zinc to Botox for cervical dystonia
This will test whether taking daily zinc citrate after a Botox injection helps people with cervical dystonia keep symptom relief longer.
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IPN10200 treatment for cervical dystonia in adults
This trial will test whether a single injection of IPN10200 (one of two doses) reduces neck posture problems, pain, and disability better than placebo in adults with cervical dystonia.
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Using Valbenazine with Botulinum Toxin for Cervical Dystonia
This study is testing if adding a medication called valbenazine to botulinum toxin injections can help people with cervical dystonia feel better and improve their quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.