Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia
ConditionCervical Dystonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRobert Chen
About this trial
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
Qualifiers
18 - 90 years of age
Confirmed diagnosis cervical dystonia
3 months since last botulinum toxin injection
Stable medications in the past month
Disqualifiers
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
Trial design
Treatments tested in this trial
- LIFUS - GPi Active
- LIFUS - DN Active
- LIFUS - Sham
Treatment groups
48 Participants
are divided into 3 treatment groupsSponsors and collaborators
Robert Chen
Lead sponsor
University Health Network, Toronto
Sponsor institution
Source ClinicalTrials.gov