Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia (NCT07690514) | Clinical Trial Compass
RecruitingNot Applicable
Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia
Canada48 participantsStarted 2024-11-18
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Timeframe: from Visit 2 prior to stimulation to up to 2 weeks
2
Resting State Functional MRI
Timeframe: from Visit 2 prior to stimulation to up to 1 week