Assessment of Children With Tic Onset in the Past 6 Months

NCT01177774 | Completed

• 2 other identifiers: 09-1700K24MH087913
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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 9 months.

Conditions

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

Keywords

functional connectivity MRI; brain volumetry; negative reinforcement; OCD; ADHD

Outcome Measures

Primary Outcomes (1)

• DSM-5 diagnosis of a chronic tic disorder at 12 months

  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.

  1 year after the onset of tics (6-12 months after the first study visit)

Study Arms (4)

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.

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.

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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 9 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

You may qualify if:

• Age 5-10
• Informed consent from a parent and assent from the child.
• New Tics Group \*\*
• tics now, but developed them only in the past 9 months.

You may not qualify if:

• \*\* Existing TS/CTD control group \*\*
• 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.
• \*\* Tic-free controls \*\*

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University School of Medicine, Movement Disorder Clinic

St Louis, Missouri, 63110, United States

Location

Related Links

• 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

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Study Officials

• Kevin J. Black, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 9, 2010
• Study Start: August 1, 2010
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Subject-level data: first data upload approximately 25 September 2018, then twice yearly through the end of the grant period.
• Access Criteria: open

Locations

US (1)