NCT07690514 Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia
| NCT ID | NCT07690514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Robert Chen |
| Condition | Cervical Dystonia |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2024-11-18 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Robert Chen, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT07690514 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Cervical Dystonia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07690514 currently recruiting?
Yes, NCT07690514 is actively recruiting participants. Contact the research team at jean-francois.nankoo@uhn.ca for enrollment information.
Where is the NCT07690514 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07690514 clinical trial?
NCT07690514 is sponsored by Robert Chen. The principal investigator is Robert Chen, MD at University Health Network, Toronto. The trial plans to enroll 48 participants.