Assessment of Children With Tic Onset in the Past 6 Months (NewTics)
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| First Received Date ICMJE | August 5, 2010 | ||||||||
| Last Updated Date | March 2, 2011 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
DSM-IV-TR diagnosis of a chronic tic disorder at 12 months [ Time Frame: 1 year after the onset of tics (6-12 months after the first study visit) ] [ Designated as safety issue: No ] Research diagnosis of a chronic tic disorder at 12 months (cases), versus those whose tics are absent at 12 months (controls), will define two groups who will be compared on their baseline status (almost a year earlier) on a quantitative measure of functional connectivity maturity, pre-tic BOLD signal, caudate nucleus volume, and several clinical and neuropsychological measures. |
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| Original Primary Outcome Measures ICMJE |
DSM-IV-TR diagnosis of a chronic tic disorder at 12 months [ Time Frame: 1 year after the onset of tics (9-12 months after the first study visit) ] [ Designated as safety issue: No ] Research diagnosis of a chronic tic disorder at 12 months (cases), versus those whose tics are absent at 12 months (controls), will define two groups who will be compared on their baseline status (almost a year earlier) on a quantitative measure of functional connectivity maturity, pre-tic BOLD signal, caudate nucleus volume, and several clinical and neuropsychological measures. |
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| Change History | Complete list of historical versions of study NCT01177774 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Assessment of Children With Tic Onset in the Past 6 Months | ||||||||
| Official Title ICMJE | Predictive Biomarkers of Conversion to Tourette Syndrome in Children With New-Onset Tics | ||||||||
| Brief Summary | The purpose of this research is to study why most children who have tics never develop Tourette syndrome but some do. In other words, we aim to find features that may predict whose tics will go away and whose tics will continue or worsen, in children ages 5 through 17 years whose first tic occurred within the past 6 months. |
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| Detailed Description | Up to 30% of all children will have a tic at some point. However, tics that last a whole year (or more) occur in only 3% of the population. Thus tic persistence may be more unusual than tic onset, yet almost no data exist on which people with recent-onset tics go on to be diagnosable with Tourette syndrome or chronic tic disorder, versus those whose tics are only transient. The overall goal of this research is to identify, prospectively, what imaging, clinical or neuropsychological features of children who just recently started ticcing will go on to develop a chronic tic disorder (including Tourette syndrome). Hypotheses are derived primarily from studies of patients with established tic disorders. Aim 1: Apply functional connectivity analysis, fMRI, structural MRI, clinical, and neuropsychological methods in the first-ever pathophysiological study of the "pre-Tourette" population. The goal is to address whether markers previously associated with chronic TS will predict in advance which children with recent-onset tics will progress to Tourette syndrome. Aim 2: Generate preliminary data for an adequately powered future study. Follow-up at 3 and 12 months will enable a preliminary comparison of children whose tics remit compared to those whose do not. Clinical and neuropsychological variables may predict poor long-term outcomes in children with tics. Additionally we will collect DNA samples from all subjects for future genetic analysis once we have a large enough sample; prior studies have examined subjects with an established tic disorder, i.e. both tic onset and tic persistence, whereas we will have an opportunity in this data set to examine genetic predictors specifically of tic persistence vs. disappearance. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: saliva |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | A convenience sample of 36 children age 5-17 who have tics now but whose first-ever tic occurred within the past 6 months. Subjects will be a convenience sample from community and clinical sources. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | November 2014 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01177774 | ||||||||
| Other Study ID Numbers ICMJE | 09-1700, K24MH087913 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Kevin J. Black, MD, Washington University School of Medicine | ||||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Washington University School of Medicine | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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