Assessment of Children With Tic Onset in the Past 6 Months (NewTics)
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|ClinicalTrials.gov Identifier: NCT01177774|
Recruitment Status : Recruiting
First Posted : August 9, 2010
Last Update Posted : June 27, 2018
|Condition or disease|
|Tourette Syndrome Tourette's Disorder Chronic Motor or Vocal Tic Disorder Transient Tic Disorder Tic Disorders Provisional Tic Disorder|
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. Study pathophysiology of recent-onset tics. Aim 1a. Identify clinical, neuropsychological, and brain imaging features that differentiate children with recent tic onset ("New Tics" group) from tic-free controls. We will test a priori hypotheses including tic suppression, inattentiveness, caudate nucleus volume, tic severity, and premonitory urges (see "Summary of hypotheses" on the 3rd page of Research Strategy). Secondary analyses will apply support vector machine (SVM) learning to a rich set of data to discover novel, multivariate differences in the New Tics group [3,45]. These data will also include tic phenomenology, psychiatric diagnosis, habit learning, motor dexterity, structural MRI, perfusion MRI, and resting state functional connectivity fMRI (rs-fcMRI).
Aim 1b. Compare New Tics subjects to a group of children who are matched for age but have already had tics for ≥1 year ("Existing TS/CTD"). Since both groups have tics, this comparison will highlight abnormalities that cannot be explained by the mere current presence of tics, including markers of chronicity or adaptation.
Aim 2. Prospective study of tic remission. We will re-evaluate New Tics subjects at the 1-year anniversary of tic onset (the accepted duration criterion for diagnosis of TS/CTD). Our pilot data show good variability in the change in tic symptom severity (i.e., change in YGTSS total tic score from baseline to followup: ΔTTS), so ΔTTS will be the primary dependent variable. We focus on outcome as a continuous variable because no reliable estimate exists for how many New Tics subjects will remit versus go on to diagnosis with TS/CTD. Remission rate also depends on definition and on the thoroughness of the follow-up evaluation .
Aim 2a. Study the physiology of tic remission by identifying changes in clinical, neuropsychological, and brain imaging variables that correlate with changes in clinical tic severity (ΔTTS). This Aim benefits from prospective observation and within-subject comparisons. The primary analysis will focus on any markers identified in Aim 1. A secondary analysis will apply machine learning methods for a data-driven approach (support vector regression: SVR).
Aim 2b. Identify predictors of improvement or worsening, i.e. clinical, neuropsychological, and brain imaging features at study entry that correlate significantly with ΔTTS. The 2 primary analyses will relate clinical outcome (ΔTTS) to tic suppression ability and caudate volume at study entry. Secondary analyses will examine other predictors using an SVR machine learning approach.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Predictive Biomarkers of Conversion to Tourette Syndrome in Children With New-Onset Tics|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||May 31, 2022|
|Estimated Study Completion Date :||May 31, 2022|
Recent-onset tics that will persist
Children between 5 to 10 years of age with recent-onset tics (first tic occurred within the past 9 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). Scheduled follow-up visits will include children over age 10 (initially enrolled at age 5-10).
Recent-onset tics that will remit
Children between 5 to 10 years of age with recent-onset tics (first tic occurred within the past 9 months) who will no longer have tics when reassessed 1 year after the first tic began (6 to 12 months after study enrollment). Scheduled follow-up visits will include children over age 10 (initially enrolled at age 5-10).
Tic-free control subjects
Children with no current or past tic disorder of similar age, sex and handedness as the children in the recent-onset tics groups.
Children with current tics whose first tics were more than 12 months ago (DSM-5 Tourette's Disorder or Persistent [Chronic] Motor or Phonic Tic Disorder), of similar age, sex and handedness as the children in the recent-onset tics groups.
- DSM-5 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) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Saint 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|