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NCT Number: NCT01440023

Developing Cognitive Training for 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.

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chronic Tic Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Psychology Clinic, University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comprehensive Behavioral Intervention for Tics (CBIT)

Behavioral

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

Computerized Response Inhibition Training

Behavioral

Twice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities.

Computerized Placebo Cognitive Training

Behavioral

Twice-weekly 45 minute computerized sessions for placebo cognitive training, which has been designed to be irrelevant for response inhibition capabilities.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Milwaukee

Other

Collaborators

  • Tourette Association of America

Registry information

Official study title

Developing Effective Response Inhibition Training for Symptom Relief in Tourette Syndrome

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 23, 2011
Registry last updated
Jan 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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