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
  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 17 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 Disorder Not Otherwise Specified

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 Washington University School of Medicine:

Primary Outcome Measures:
  • 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

saliva


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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: 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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  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: Mary L Creech, RN, LCSW 317-362-7651 maryc@npg.wustl.edu
Contact: Samantha Blankenship, MSW 314-362-6514 blankenships@npg.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine, Movement Disorder Clinic Recruiting
St,. Louis, Missouri, United States, 63110
Contact: Mary L. Creech, RN, LCSW    314-362-7651    maryc@npg.wustl.edu   
Contact: Samantha Blankenship, MSW    314-362-6514    blankenships@npg.wustl.edu   
Principal Investigator: Kevin J. Black, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Kevin J. Black, MD Washington University School of Medicine
  More Information

Additional Information:
No publications provided

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
Study First Received: August 5, 2010
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
functional connectivity MRI
brain volumetry
negative reinforcement
OCD
ADHD

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

ClinicalTrials.gov processed this record on July 20, 2014