tDCS in Tourette (TIC-TDCS)

N/AUnknownNCT03401996

University of Calgary30 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tourette Syndrome

Interventions

1 mA tDCS over bilateral SMADEVICE

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.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Clinical Neurosciences, University of Calgary

Calgary, Alberta, Canada

RECRUITING

Outcomes

Primary Outcomes

Tic severity total subscore on the Yale Global Tic Severity Scale (YGTSS)

The Yale Global Tic Severity Scale is the most extensively deployed scale worldwide for measuring tic severity. It requires an experienced clinician using all available information to rate motor and phonic tic severity during the previous week. Five dimensions (number, frequency, intensity, complexity, and interference) of motor and phonic tics are rated separately on a six point Likert-type scale (zero-five), with each point anchored to descriptive statements and relevant examples. The global score has a zero-one hundred range, composed by severity and overall impairment scores, each of which having a zero-fifty range. Higher values indicate worse outcome.

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

Secondary Outcomes

Tic inhibition potential on the Modified Video-Based Tic Rating Scale (MVBTRS)

Tic suppression will be measured using the Modified Rush Video-Based Tic Rating Scale through a 5 min video recording (2.5 min head and shoulders and 2.5 min whole body view). The scoring method consists of combining scores rating tic distribution (number of body areas involved, from 0 to 4), tic frequency (number of motor and phonic tics expressed from 0 to 4), and tic severity (for motor tics and for phonic tics, from 0 to 4). The total score range is 0 to 20, with higher values indicating worse outcome. Tic suppression will be expressed as suppression potency (IP), defined as follows: IP = RF-RI/RF, where RF is the Rush score during 'free' ticcing and RI the Rush score during tic suppression. Thus, the higher the IP value, the more efficient the suppression potency.

Central Contacts

Yamile Jasaui, MSc

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.