Clinical trial Recruiting at 1 site Interventional Ages 18 to 90

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 typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment48 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedNovember 18, 2024
Main results expectedDecember 2028
Study endsDecember 2029
Registry record updatedJuly 8, 2026
Trial IDNCT07690514 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

  • Toronto Western Hospital
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.