Assessment of Children With Tic Onset in the Past 6 Months
NCT ID: NCT01177774
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
99 participants
OBSERVATIONAL
2010-08-31
2023-07-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 \[4\].
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
No interventions assigned to this group
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).
No interventions assigned to this group
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.
No interventions assigned to this group
Existing TS/CTD
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent from a parent and assent from the child.
* New Tics Group \*\*
* tics now, but developed them only in the past 9 months.
* children who meet DSM-5 criteria for Tourette's Disorder or Persistent Tic Disorder at enrollment
* matched to children from the New Tics group on age (within 1 year), sex, handedness, and ADHD status.
Exclusion Criteria
\*\* Tic-free controls \*\*
5 Years
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kevin J. Black, M.D.
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kevin J. Black, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine, Movement Disorder Clinic
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information about this study: Predictive Biomarkers of Conversion to Tourette Syndrome in Children with New-Onset Tics
Click here for more information about this study: Predictive Biomarkers of Conversion to Tourette Syndrome in Children with New-Onset Tics
Tourette Syndrome resources
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09-1700
Identifier Type: -
Identifier Source: org_study_id