Clinical trial NCT03401996: tDCS in Tourette (TIC-TDCS)
Official title: tDCS Over the Supplemental Motor Area for the Treatment of Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tourette Syndrome
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind randomized, sham-controlled clinical trial of 1 mA bilateral supplementary motor area in adolescents/adults with Tourette syndrome (TS). The primary objectives are to assess and quantify the safety and efficacy on tic severity of 5 inhibitory sessions of active vs. sham tDCS sessions during active tic suppression, and to explore the differences in brain functional activity before and after 5 sessions of active or sham cathodal tDCS in adolescents and adults with TS. Secondary objectives include the assessment of the severity of comorbidities after 5 inhibitory tDCS sessions.


Eligibility criteria: Inclusion Criteria:

* Participants who meet Diagnostic and Statistical Manual of Mental Disorders criteria for TS (APA, DSM V).
* 16 years of age or older.
* A "moderately ill" or worse score on the Clinical Global Impression Severity scale (CGI-S).
* A total motor tic or vocal tic severity score greater or equal to 15/25 on the Yale Global Tic Severity Scale (YGTSS) or a combined score greater than 22/50.
* Participants should be either un-medicated or on stable medication treatment for tics for the previous 3 months. If receiving botulinum toxin treatment, their enrolment should be at least 16 weeks after the last treatment session.
* Psychiatric comorbidities should be clinically stable; treatment has not changed in the last 3 months.

Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

* Have a metal object/implant in their brain, skull, scalp, or neck.
* Have an implantable device (e.g., cardiac pacemaker).
* Have a diagnosis of epilepsy or cardiac disease.
* Have a history of traumatic brain injury, learning disability or dyslexia.
* Have a severe impediment in vision or hearing.

Primary outcomes:
measure: Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)
timeFrame: Immediately after last tDCS session
measure: Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)
timeFrame: 1 week after end of intervention
Secondary outcomes:
measure: Tic inhibition potential on the Modified Video-Based Tic Rating Scale (MVBTRS)
timeFrame: Immediately after and 1 week after last tDCS session
measure: Adverse effects
timeFrame: Immediately after and 1 week after last tDCS session
measure: Tourette Syndrome Clinical Global Impression (TS-CGI)
timeFrame: Immediately after and 1 week after last tDCS session
measure: Individualized-Premonitory Urge for Tics Scale (iPUTS)
timeFrame: Immediately after and 1 week after last tDCS session
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Immediately after and 1 week after last tDCS session
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Department of Clinical Neurosciences, University of Calgary
state: Alberta
Study officials:
affiliation: Department of Clinical Neurosciences, University of Calgary
name: Davide Martino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: