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Completed

NCT Number: NCT00675675

Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

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.

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Key information

Conditions

Tic Disorder Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tic Disorders Tics Tourette Syndrome

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90024, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Comprehensive Behavioral Intervention for Tics (CBIT)

Behavioral

Habit Reversal Training plus functional assessment/intervention designed to identify and ameliorate tic triggers (antecedents) and maintaining consequences.

Minimal Contact Waitlist

Behavioral

Bimonthly phone check-in to assess clinical status and enhance subject retention

Primary outcomes

  1. Clinical Global Impressions - Improvement

    Time frame: Wks 0, 5, 10

Secondary outcomes

  1. Yale Global Tic Severity Scale

    Time frame: Wks 0, 5, 10

Sponsors and collaborators

Lead sponsor

John Piacentini

Other

Registry information

Official study title

TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 12, 2008
Registry last updated
Aug 21, 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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