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Assessment of Children With Tic Onset in the Past 6 Months (NewTics)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Kevin J. Black, MD, Washington University School of Medicine
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kevin J. Black, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01177774
First received: August 5, 2010
Last updated: June 8, 2017
Last verified: June 2017
  Purpose
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 10 years whose first tic occurred within the past 6 months.

Condition
Tourette Syndrome Tourette's Disorder Chronic Motor or Vocal Tic Disorder Transient Tic Disorder Tic Disorders Provisional Tic Disorder

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Predictive Biomarkers of Conversion to Tourette Syndrome in Children With New-Onset Tics

Resource links provided by NLM:


Further study details as provided by Kevin J. Black, MD, Washington University School of Medicine:

Primary Outcome Measures:
  • 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
saliva

Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: May 31, 2022
Estimated Primary Completion Date: May 31, 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
Recent-onset tics that will persist
Children between 5 to 10 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 10 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).

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. 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.

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. A convenience sample of children age 5-10 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.
  2. A control group who already meets criteria for a diagnosis of a chronic tic disorder, matched for age, sex, handedness, and ADHD
  3. A control group who has no tics, matched for age, sex, handedness, and ADHD
Criteria

** All subjects **

Inclusion Criteria:

  • Age 5-10
  • Informed consent from a parent and assent from the child.

    • New Tics Group **

Inclusion Criteria:

  • tics now, but developed them only in the past 6 months.

Exclusion criteria: secondary tics, another neurological disorder (not counting migraine), structural brain disease, severe systemic illness, nonproficiency in the English language, and psychiatric illness including mental retardation, autism, substance dependence, current substance abuse, primary psychotic illness, bipolar disorder and current major depression. Psychoactive medications are allowed if their dose has not changed in the past month.

** Existing TS/CTD control group **

Inclusion criteria:

  • children who meet DSM-5 criteria for Tourette's Disorder or Chronic Tic Disorder (DSM-5 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: same as for the New Tics group.

** Tic-free controls **

Inclusion criteria: tic-free children matched to children from the New Tics group on age (within 1 year), sex, handedness, and ADHD status.

Exclusion criteria: current or past tic disorder in the subject or a first-degree relative, plus the exclusions listed for the New Tics group.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177774

Contacts
Contact: Emily C Bihun, M.Ed. 317-362-2083 BihunE@npg.wustl.edu
Contact: Samantha Ranck, MSW 314-362-6514 RanckS@npg.wustl.edu

Locations
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         
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Kevin J. Black, MD Washington University School of Medicine
Principal Investigator: Bradley L Schlaggar, MD PhD Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Kevin J. Black, MD, Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01177774     History of Changes
Other Study ID Numbers: 09-1700
K24MH087913 ( US NIH Grant/Contract Award Number )
Study First Received: August 5, 2010
Last Updated: June 8, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Beginning in June, 2017, all data other than PHI will follow the NIMH RDoC data sharing policy.

Keywords provided by Kevin J. Black, MD, Washington University School of Medicine:
functional connectivity MRI
brain volumetry
negative reinforcement
OCD
ADHD

Additional relevant MeSH terms:
Disease
Syndrome
Tourette Syndrome
Tic Disorders
Tics
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 28, 2017