tDCS in Tourette (TIC-TDCS)

University of Calgary

Status: Unknown

Conditions: Tourette Syndrome

Treatments: Device: 1 mA tDCS over bilateral SMA

Study type: Interventional

Funder types: Other

Identifiers

NCT03401996

REB17-1615

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Real tDCS

Experimental group

Treatment:

Device: 1 mA tDCS over bilateral SMA

Sham tDCS

Sham Comparator group

Treatment:

Device: 1 mA tDCS over bilateral SMA