Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders - Full Text View

Sponsored by:	University of California, Los Angeles
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00675675

Purpose

The study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare and contrast hypothesized mechanisms related to increased tic control associated with Habit Reversal Training, a behavioral treatment that been previously shown to be effective in treating CTD. We also seek to better understand the relationship between fMRI and quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist nonresponders will be provided with 10 weeks of HRT. Study assessments, including a neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10, and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.

Condition	Intervention
Tic Disorder	Behavioral: Habit Reversal Training Behavioral: Minimal Contact Waitlist

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Clinical Global Impressions - Improvement [ Time Frame: Wks 0, 5, 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Yale Global Tic Severity Scale [ Time Frame: Wks 0, 5, 10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Habit Reversal Training	Behavioral: Habit Reversal Training Behavioral treatment consisting of: awareness training to enhance awareness of tic urge or expression competing response training to teach a motoric behavior performed contingent on initial awareness of urge or tic social support to reinforce use of the first two components
2: Placebo Comparator Minimal Contact Waitlist	Behavioral: Minimal Contact Waitlist Biweekly phone contact to monitor child's clinical status.

Eligibility

Ages Eligible for Study:	9 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV diagnostic criteria for CTD (CMVT or TS)
Clinical Global Impressions - Severity Score > 3 (moderately ill or worse)
YGTSS Total Score > 14 (or Total Score > 10 if CTD with motor tics only)
Unmedicated or on stable psychotropic medication for at least 6 weeks prior to study entry, with no planned changes for duration of study participation
Child is fluent English speaker
Parental Informed Consent and Child Informed Assent.

Exclusion Criteria:

Total YGTSS Score>35 (Cases above this threshold otherwise eligible will be reviewed by Clinical Caseness Panel for potential study participation)
IQ < 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)
Problematic Substance Use or DSM-IV Conduct Disorder in past 3 months
Lifetime DSM-IV diagnosis of PDD, Mania, or Psychotic Disorder
Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current study
Previous treatment with four or more sessions of HRT for tics
Contraindication to fMRI scan

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675675

Contacts

Contact: Joni Zuckerbrow-Miller	310-295-7667	jzuckerbrow@mednet.ucla.edu
Contact: Lu Lu	310-825-0122	lulu@mednet.ucla.edu

Locations

United States, California
University of California, Los Angeles	Recruiting
Los Angeles, California, United States, 90024
Contact: Fiona Whelan, M.S. 310-825-7874 fwhelan@mednet.ucla.edu
Principal Investigator: James McCracken, M.D.
Sub-Investigator: John Piacentini, Ph.D.
Sub-Investigator: Russell Poldrack, Ph.D.

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Study Director:	John Piacentini, Ph.D.	University of California, Los Angeles
Principal Investigator:	James McCracken, M.D.	University of California, Los Angeles

More Information

UCLA Child OCD, Anxiety, and Tic Disorders Program This link exits the ClinicalTrials.gov site

Responsible Party:	UCLA ( John Piacentini, Ph.D. )
Study ID Numbers:	UCLAP500772484, P50 MH077248
Study First Received:	May 7, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00675675
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

Tourette Syndrome
Chronic Tic Disorder
Tics
Behavior Therapy

Habit Reversal Training
Child
Adolescent
Neuroimaging

Study placed in the following topic categories:

Signs and Symptoms
Mental Disorders
Movement Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Central Nervous System Diseases

Gilles de la Tourette's syndrome
Tourette Syndrome
Tic Disorders
Dyskinesias
Tics

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009