Developing Cognitive Training for Tourette Syndrome

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Brief Title

Developing Cognitive Training for Tourette Syndrome

Official Title

Developing Effective Response Inhibition Training for Symptom Relief in Tourette Syndrome

Brief Summary

      Many researchers suspect that individuals with Tourette Syndrome (TS) may have a poor
      cognitive ability (i.e., response inhibition; RI) that is essential to inhibit inappropriate
      response such as vocal or motor tics. The investigators aim to test whether a
      well-established behavior therapy for TS can be improved by increasing the individual's RI
      capabilities. To this end, 20 children will be randomly assigned to behavior therapy with
      computer-based RI training or behavior therapy with placebo computer-based cognitive
      training. The investigators will test the hypothesis that computer-based RI training can be a
      useful addition to the well-established behavior therapy to enhance its therapeutic effect.
    

Detailed Description

      The current research seeks to examine the feasibility of using a computer-based RI training
      program as an adjunctive intervention for the Comprehensive Behavioral Intervention for Tics
      (CBIT). Our central hypothesis is that cognitive training designed to enhance RI will
      potentiate treatment outcomes of CBIT. To this end, the investigators will conduct a two-arm
      placebo-controlled double-blind trial, in which 20 children with TS will be randomly assigned
      to CBIT with computerized RI training (CBIT+RIT; n=10) or CBIT with placebo computer training
      (CBIT +PLT; n=10). CBIT consists of eight weekly sessions that present awareness training,
      competing response training, relaxation training and functional contingency management in a
      manualized format. The adjunctive computer training (RIT or PLT) will be delivered during the
      first 4 weeks of CBIT/HRT (i.e. 8 twice-weekly 40-min sessions). Tic symptoms and RI
      capabilities will be assessed at baseline, mid-treatment, post-treatment, and 1 month
      follow-up. This project is expected to increase our understanding about the nature of
      response inhibition deficits in TS and generate knowledge that will guide the development of
      effective cognitive interventions for TS.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Change in scores on the Yale Global Tic Severity Scale (YGTSS) across baseline, 4-week, 8-week, and 12 week assessments. during and after the treatment from baseline

Secondary Outcome

 Change in scores on the Clinical Global Impression Severity and Improvement (CGI-S and CGI-I) across baseline, 4-week, 8-week, and 12 week assessments.

Condition

Tourette Syndrome

Intervention

Comprehensive Behavioral Intervention for Tics (CBIT)

Study Arms / Comparison Groups

 CBIT + Response Inhibition Training
Description:  CBIT is an 8 session treatment protocol held over 10 weeks. In CBIT, core components are implemented across the various therapy sessions. These core components include habit reversal training (HRT), functional assessment/function-based interventions, and a behavioral reward program for the child. Each core component is briefly described below. HRT/CBIT involves three components, awareness training, competing response training, and social support training (Woods, Twohig, Roloff, & Flessner, 2003). For this condition, CBIT will be combined with adjunctive computerized response inhibition training, which will be delivered over the first 4 weeks of the CBIT treatment.

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

Behavioral

Estimated Enrollment

20

Start Date

August 2011

Completion Date

December 2014

Primary Completion Date

December 2014

Eligibility Criteria

        Inclusion Criteria:

          -  age between 9 and 17

          -  a diagnosis of TS or chronic tic disorder on the structured diagnostic interview

          -  moderate to severe levels of tic symptoms (YGTSS total score > 13 for TS, or > 9 for
             CTD), and (d) IQ > 80.

        Exclusion Criteria:

          -  current substance abuse or dependence

          -  current or past psychotic disorder, bipolar disorder, or schizophrenia

          -  4 or more previous sessions of behavioral treatments for tic

          -  significant suicidal ideation and/or attempts within the past 3 months

          -  any recent (in the previous month) or planned change in medication for tic symptoms.
      

Gender

All

Ages

9 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Han Joo Lee, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01440023

Organization ID

TSA-2011-Lee

Secondary IDs

TSA

Responsible Party

Principal Investigator

Study Sponsor

University of Wisconsin, Milwaukee

Collaborators

 Tourette Association of America

Study Sponsor

Han Joo Lee, Ph.D., Principal Investigator, University of Wisconsin, Milwaukee


Verification Date

January 2015