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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
LIFUS - GPi Active
DeviceBilateral thetaburst LIFUS stimulation to the globus pallidus
LIFUS - DN Active
DeviceBilateral thetaburst LIFUS stimulation to dentate nucleus
LIFUS - Sham
DeviceBilateral sham (placebo) LIFUS stimulation
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: LIFUS - GPiExperimental treatment 1 intervention
Group B: LIFUS - DNExperimental treatment 1 intervention
Group C: LIFUS - ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Dystonia Assessment
Time frame
from Visit 2 prior to stimulation to up to 2 weeks2
Resting State Functional MRI
Time frame
from Visit 2 prior to stimulation to up to 1 week3
Dystonia non-motor symptoms questionnaire (DNMSQuest)
Dystonia Assessment
Time frame
from Visit 2 prior to stimulation to up to 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Robert Chen
Lead sponsor
University Health Network, Toronto
Sponsor institution
Source ClinicalTrials.gov