Clinical trial NCT01440023: Developing Cognitive Training for Tourette Syndrome
Official title: Developing Effective Response Inhibition Training for Symptom Relief in Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tourette Syndrome
Chronic Tic Disorders
Keywords: tic disorder
tourette syndrome
habit reversal
response inhibition
cognitive retraining
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: Tourette Association of America
First posted: 2011-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)
Secondary outcomes:
measure: 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.
timeFrame: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: The Psychology Clinic, University of Wisconsin-Milwaukee
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Han Joo Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: