Developing Cognitive Training for Tourette Syndrome

Phase 1

Completed

• Conditions: Tourette Syndrome; Chronic Tic Disorders

• Registration Number: NCT01440023
• Lead Sponsor: University of Wisconsin, Milwaukee

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

The Psychology Clinic, University of Wisconsin-Milwaukee; 🇺🇸 Milwaukee, Wisconsin, United States