tDCS in Tourette (TIC-TDCS)

NCT ID: NCT03401996

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-04-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Real tDCS

Group Type: EXPERIMENTAL

1 mA tDCS over bilateral SMA

Intervention Type: 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.

Sham tDCS

Group Type: SHAM_COMPARATOR

1 mA tDCS over bilateral SMA

Intervention Type: 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.

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Davide Martino, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Neurosciences, University of Calgary

Locations

Department of Clinical Neurosciences, University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Yamile Jasaui, MSc

Role: CONTACT

yjasauic@ucalgary.ca

001-403-220-4992

Facility Contacts

Yamile Jasaui, MSc

Role: primary

yjasauic@ucalgary.ca

001-403-220-4992

Other Identifiers

REB17-1615

Identifier Type: -

Identifier Source: org_study_id