Developing Cognitive Training for Tourette Syndrome

NCT01440023 | Completed Phase 1

• 2 other identifiers: TSA-2011-LeeTSA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome; Chronic Tic Disorders

Keywords

tic disorder; tourette syndrome; habit reversal; response inhibition; cognitive retraining

Outcome Measures

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

  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 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.

  At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)

Study Arms (2)

CBIT + Response Inhibition Training

EXPERIMENTAL

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); Behavioral: Computerized Response Inhibition Training

Experimental: CBIT + Placebo Computer Training

PLACEBO COMPARATOR

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); Behavioral: Computerized Placebo Cognitive Training

Interventions

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.

Also known as: Habit Reversal for Tourette Syndrome

CBIT + Response Inhibition Training; Experimental: CBIT + Placebo Computer Training

Computerized Response Inhibition Training BEHAVIORAL

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

CBIT + Response Inhibition Training

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.

Experimental: CBIT + Placebo Computer Training

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• current substance abuse or dependence
• current or past psychotic disorder, bipolar disorder, or schizophrenia
• 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.

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• Tourette Association of America: collaborator

Study Sites (1)

The Psychology Clinic, University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Han Joo Lee, Ph.D.

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychology

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 23, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

US (1)