Developing Cognitive Training for Tourette Syndrome

January 13, 2015 updated by: Han Joo Lee, University of Wisconsin, Milwaukee

Developing Effective Response Inhibition Training for Symptom Relief in Tourette Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • The Psychology Clinic, University of Wisconsin-Milwaukee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBIT + Response Inhibition Training
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.
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
CBIT is an 8 session treatment protocol held over 10 weeks. Its 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.
Other Names:
  • Habit Reversal for Tourette Syndrome
Behavioral: Computerized Response Inhibition Training
Twice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities.
Placebo Comparator: Experimental: CBIT + Placebo Computer Training
In this condition, participants receive the same package of CBIT treatment, which consists of awareness training, competing response training, and social support training (Woods, Twohig, Roloff, & Flessner, 2003). Additionally, the standard CBIT treatment is combined with computer-based placebo cognitive training that is irrelevant to the target cognitive ability (i.e., response inhibition). During the first 4 weeks of the CBIT treatment, participants will receive 8 sessions of placebo cognitive training.
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
CBIT is an 8 session treatment protocol held over 10 weeks. Its 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.
Other Names:
  • Habit Reversal for Tourette Syndrome
Behavioral: Computerized Placebo Cognitive Training
Twice-weekly 45 minute computerized sessions for placebo cognitive training, which has been designed to be irrelevant for response inhibition capabilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)
The YGTSS is a well-validated instrument that produces severity ratings for motor and vocal tics, impairment caused by the tics, and an overall severity score of tic symptoms.
At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)
The CGI-S and CGI-I are clinicianadministered rating scales that have been widely used in treatment outcome research for over 25 years. The current research will use the CGI scale to evaluate the overall severity and improvement in tic symptoms.
At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Milwaukee

Collaborators

Tourette Association of America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (Estimate)

September 23, 2011

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSA-2011-Lee
  • TSA (Other Identifier: Tourette Syndrome Association)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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