Assessment of Children With Tic Onset in the Past 6 Months (NewTics)
Chronic Motor or Vocal Tic Disorder
Transient Tic Disorder
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Predictive Biomarkers of Conversion to Tourette Syndrome in Children With New-Onset Tics|
- 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.
Biospecimen Retention: Samples With DNA
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Recent-onset tics that will persist
Children between 5 to 17 years of age with recent-onset tics (first tic occurred within the past 6 months) who, when reassessed at 1 year after the first tic began (i.e. 6-12 months after study enrollment) will turn out to meet criteria for a chronic tic disorder (including Tourette syndrome).
Recent-onset tics that will remit
Children between 5 to 17 years of age with recent-onset tics (first tic occurred within the past 6 months) who will no longer have tics when reassessed 1 year after the first tic began (6 to 12 months after study enrollment).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177774
|Contact: Emily C Bihun, M.Ed.||317-362-2083||BihunE@npg.wustl.edu|
|Contact: Samantha Ranck, MSW||314-362-6514||RanckS@npg.wustl.edu|
|United States, Missouri|
|Washington University School of Medicine, Movement Disorder Clinic||Recruiting|
|St,. Louis, Missouri, United States, 63110|
|Contact: Emily C. Bihun, M.Ed. 314-362-2083 BihunE@npg.wustl.edu|
|Contact: Samantha Ranck, MSW 314-362-6514 RanckS@npg.wustl.edu|
|Principal Investigator: Kevin J. Black, MD|
|Principal Investigator:||Kevin J. Black, MD||Washington University School of Medicine|
|Principal Investigator:||Bradley L Schlaggar, MD PhD||Washington University School of Medicine|