Brief Title
tDCS in Tourette (TIC-TDCS)
Official Title
tDCS Over the Supplemental Motor Area for the Treatment of Tourette Syndrome
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.
Study Type
Interventional
Primary Outcome
Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)
Secondary Outcome
Tic inhibition potential on the Modified Video-Based Tic Rating Scale (MVBTRS)
Condition
Tourette Syndrome
Intervention
1 mA tDCS over bilateral SMA
Study Arms / Comparison Groups
Real tDCS
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Start Date
May 1, 2018
Completion Date
April 30, 2021
Primary Completion Date
February 1, 2021
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.
Gender
All
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Davide Martino, MD, PhD, 001-403-220-4992, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03401996
Organization ID
REB17-1615
Responsible Party
Sponsor
Study Sponsor
University of Calgary
Study Sponsor
Davide Martino, MD, PhD, Principal Investigator, Department of Clinical Neurosciences, University of Calgary
Verification Date
March 2020