tDCS in Tourette (TIC-TDCS)

NCT03401996 | Unknown

• 1 other identifier: REB17-1615
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Immediately after last tDCS session

• 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.

  1 week after end of intervention

Secondary Outcomes (5)

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

  Immediately after and 1 week after last tDCS session

• Adverse effects

  Immediately after and 1 week after last tDCS session

• Tourette Syndrome Clinical Global Impression (TS-CGI)

  Immediately after and 1 week after last tDCS session

• Individualized-Premonitory Urge for Tics Scale (iPUTS)

  Immediately after and 1 week after last tDCS session

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Immediately after and 1 week after last tDCS session

Study Arms (2)

Real tDCS

EXPERIMENTAL

Device: 1 mA tDCS over bilateral SMA

Sham tDCS

SHAM COMPARATOR

Device: 1 mA tDCS over bilateral SMA

Interventions

1 mA tDCS over bilateral SMA DEVICE

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.

Real tDCS; Sham tDCS

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who meet Diagnostic and Statistical Manual of Mental Disorders criteria for TS (APA, DSM V).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Department of Clinical Neurosciences, University of Calgary

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Davide Martino, MD, PhD

  Department of Clinical Neurosciences, University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yamile Jasaui, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 17, 2018
• Study Start: May 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: April 30, 2021
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)