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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 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
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 11, 2013
Last verified: June 2013

August 5, 2010
June 11, 2013
August 2010
November 2014   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01177774 on ClinicalTrials.gov Archive Site
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Assessment of Children With Tic Onset in the Past 6 Months
Predictive Biomarkers of Conversion to Tourette Syndrome in Children With New-Onset Tics

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

saliva

Non-Probability Sample

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.

  • Tourette Syndrome
  • Tourette's Disorder
  • Chronic Motor or Vocal Tic Disorder
  • Transient Tic Disorder
  • Tic Disorder Not Otherwise Specified
Not Provided
  • 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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • We will study a convenience sample of 36 children age 5-17 who have tics now, but developed them only in the past 6 months; and
  • Informed consent from a parent and assent from the child.

Exclusion Criteria:

  • Secondary tics,
  • Known structural brain disease,
  • Other movement disorders including essential tremor,
  • Neurological disorders other than migraine, including cerebral palsy and epilepsy
  • Moderate to severe mental retardation,
  • Autism,
  • Current major depression,
  • Lifetime substance dependence or current substance abuse (DSM-IV),
  • Lifetime manic episode or psychotic disorder (DSM-IV),
  • Moderate to severe current systemic illness,
  • Antipsychotics or tetrabenazine taken for >1 week ever or within the past month,
  • Current use of certain medications,
  • Lack of proficiency in the English language that will affect the informed consent process or the psychological testing.
  • Additionally, children will be excluded from MRI if they have contraindications to MRI, a positive pregnancy test (females after menarche), or current use of certain medications.
Both
5 Years to 17 Years
No
Contact: Mary L Creech, RN, LCSW 317-362-7651 maryc@npg.wustl.edu
Contact: Samantha Blankenship, MSW 314-362-6514 blankenships@npg.wustl.edu
United States
 
NCT01177774
09-1700, K24MH087913
No
Kevin J. Black, MD, Washington University School of Medicine
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Principal Investigator: Kevin J. Black, MD Washington University School of Medicine
Washington University School of Medicine
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP