CompletedNot Applicable

Assessment of Children With Tic Onset in the Past 6 Months

United States99 participantsStarted 2010-08

Plain-language 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.

Who can participate

Age range

5 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

\*\* 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 9 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 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT01177774

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-13

View on ClinicalTrials.gov More Tourette Syndrome trials