Clinical trial NCT00675675: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders
Official title: TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tic Disorder
Keywords: Tourette Syndrome
Chronic Tic Disorder
Tics
Behavior Therapy
Habit Reversal Training
Child
Adolescent
Neuroimaging
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 53
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Clinical Global Impressions - Improvement
timeFrame: Wks 0, 5, 10
Secondary outcomes:
measure: Yale Global Tic Severity Scale
timeFrame: Wks 0, 5, 10
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: John Piacentini, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of California, Los Angeles
name: James McCracken, M.D.
role: PRINCIPAL_INVESTIGATOR
References: