Developing Cognitive Training for Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Developing Effective Response Inhibition Training for Symptom Relief in Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440023
• Other study ID #: TSA-2011-Lee
• Secondary ID: TSA
• Status: Completed
• Phase: Phase 1
• First received: September 2, 2011
• Last updated: January 13, 2015
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of Wisconsin, Milwaukee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Tic Disorders
• Syndrome
• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

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.
• Computerized Response Inhibition Training
Twice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities.
• 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.

Locations

Country	Name	City	State
United States	The Psychology Clinic, University of Wisconsin-Milwaukee	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee	Tourette Association of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	No
Secondary	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.	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)	No