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Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia

RecruitingNAAges 18 Years - 90 YearsAllRobert Chen
NCT07690514 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • LIFUS - GPi Active
  • LIFUS - DN Active
  • LIFUS - Sham
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Where

1 site
Toronto Western Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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