Tourette SyndromeNewTicsNCT01177774
Assessment of Children With Tic Onset in the Past 6 Months
An observational study of Tourette Syndrome and Tourette's Disorder, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Tourette Syndrome, Tourette's Disorder, Chronic Motor or Vocal Tic Disorder
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 13 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine, Movement Disorder Clinic
St Louis, Missouri, 63110
About this study
Official title: 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 10 years whose first tic occurred within the past 9 months.
Read the 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.
- 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
- Medical subject headings
- Tourette Syndrome, Tic Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after the onset of tics (6-12 months after the first study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startAug 2010
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kevin J. Black, M.D., Washington University School of Medicine
- Investigators
- Kevin J. Black, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177774
- Sponsor's protocol ID
- 09-1700
- Other IDs
- K24MH087913
- Acronym
- NewTics
- Status last verified
- Nov 2023
- First submitted
- 5 Aug 2010
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Beginning in June, 2017, all data other than PHI will follow the NIMH RDoC data sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Biomarkers of Conversion to Tourette Syndrome in Children With New-Onset Tics
- ClinicalTrials.gov ID
- NCT01177774
- Acronym / sponsor ID
- NewTics / 09-1700
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2010
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (8 listed)
- Age 5-10
- Informed consent from a parent and assent from the child.
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Click here for more information about this study: Predictive Biomarkers of Conversion to Tourette Syndrome in Children with New-Onset TicsLink provided by the sponsor.
- Click here for more information about this study: Predictive Biomarkers of Conversion to Tourette Syndrome in Children with New-Onset TicsLink provided by the sponsor.
- Tourette Syndrome resourcesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Beginning in June, 2017, all data other than PHI will follow the NIMH RDoC data sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin J. Black, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome and Tourette's Disorder, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.