Recruiting

tDCS

Sponsor:

University of Calgary

Code:

NCT03401996

Conditions

Tourette Syndrome

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

1 mA tDCS over bilateral SMA

Study Details

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.

Conditions

Tourette Syndrome

Study ID

NCT03401996

Start date

May 1, 2018

Status verified date

Mar, 2020

Completion date

Apr 30, 2021

Anticipated

Primary completion date

Feb 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Real tDCS

sham comparator: Sham tDCS

Interventions

1 mA tDCS over bilateral SMA

A 1mA direct current will be delivered through two 5cm x 5cm saline-soaked surface sponge electrodes by a battery-driven, constant-current stimulator (Neuroconn DC stimulator). First, the SMA will be identified based on the guidelines of the international 10-20 electrode system. The tDCS will then be applied using the following procedure:

1. The head of participants will be measured to find the 'vertex' (top) of the head. This point will be used as a landmark to locate the SMA. This region corresponds to the FCZ (e.g., Legon et al., 2013).
2. The return electrode will be placed over the mastoids. Once the electrodes are in position, cathodal tDCS will be applied at 1mA for 15 minutes, 2 times a day with a resting period of 20 minutes in between treatment periods, for 5 consecutive days.

Primary outcome measure

  • Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Immediately after last tDCS session ]
  • Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS) [ Time Frame: 1 week after end of intervention ]

Central Contacts and Locations

Central contacts

Yamile Jasaui, MSc

001-403-220-4992yjasauic@ucalgary.ca

Locations

Department of Clinical Neurosciences, University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

Yamile Jasaui, MSc

001-403-220-4992yjasauic@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Mar 25, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2020-03-25.