TRECC: Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Clinical Global Impressions - Improvement
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Clinical Global Impressions - Improvement
时间窗: Wks 0, 5, 10
次要结局
- Yale Global Tic Severity Scale(Wks 0, 5, 10)
研究者
John Piacentini
Professor in Residence
University of California, Los Angeles