tDCS in Tourette (TIC-TDCS)

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Tourette syndrome
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Brief Title

tDCS in Tourette (TIC-TDCS)

Official Title

tDCS Over the Supplemental Motor Area for the Treatment of Tourette Syndrome

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.

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Tourette Syndrome

Intervention

1 mA tDCS over bilateral SMA

Study Arms / Comparison Groups

 Real tDCS
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

30

Start Date

May 1, 2018

Completion Date

April 30, 2021

Primary Completion Date

February 1, 2021

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.

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Davide Martino, MD, PhD, 001-403-220-4992, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT03401996

Organization ID

REB17-1615

Responsible Party

Sponsor

Study Sponsor

University of Calgary

Study Sponsor

Davide Martino, MD, PhD, Principal Investigator, Department of Clinical Neurosciences, University of Calgary

Verification Date

March 2020