Tourette Syndrome in ChildrenNCT05566496
The Findings of Magnetic Resonance Imaging in Subtypes of Tics-related Disorders
An observational study of Tourette Syndrome in Children, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The findings of resting-state functional magnetic resonance imaging and diffusion spectrum imaging in subtypes of tics-related disorders Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome in Children
- What is being tested?
- Brain MRI
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Oct 2015to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: We enrolled treatment-naive Tourette syndrome or chronic tic disorder pediatric patients for Tourette group and healthy age- and gender-matched participants for healthy control
Who may be able to join
- Age less than 18 years old
- Diagnosed as Tourette syndrome or chronic tic disorders
Who cannot join
- History of neuropsychiatric disorders
- Already receive treatment for Tourette syndrome/chronic tics disorder
- Have some device not allowed for MRI scan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Children Hospital Pediatric Neurology Department
Taipei, 100
Wang-Tso Lee, (886)2-23123456 ext. 71618, leeped@hotmail.com
About this study
Official title: The Findings of Resting-state Functional Magnetic Resonance Imaging, Diffusion Spectrum Imaging, and Wideband Magnetic Resonance Imaging in Subtypes of Tics-related Disorders
The findings of resting-state functional magnetic resonance imaging and diffusion spectrum imaging in subtypes of tics-related disorders
- Conditions
- Tourette Syndrome in Children
- Being tested
- Brain MRI
- Keywords
- MRI, pediatric neurology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIDiagnostic test
All participants receive brain MRI evaluation and clinical evaluation of tic severity.
| Study group | Role | What they receive |
|---|---|---|
| Tourette | Age less than 18 years old Diagnosed as Tourette syndrome or chronic tic disorders No other neuropsychiatric disorders Receives: Diagnostic Test: Brain MRI | |
| Healthy | Age less than 18 years old No other neuropsychiatric disorders Receives: Diagnostic Test: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between healthy and Tourette group
Difference of MRI result between healthy and Tourette group
Measured: 2 years after enrollment for primary evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start20 Oct 2015
- Primary completion1 Aug 2025 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang-Tso Lee, Principal investigator, National Taiwan University Children Hospital Pediatric neurology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566496
- Sponsor's protocol ID
- 201503062RIND
- Status last verified
- Aug 2024
- First submitted
- 30 Sep 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Findings of Resting-state Functional Magnetic Resonance Imaging, Diffusion Spectrum Imaging, and Wideband Magnetic Resonance Imaging in Subtypes of Tics-related Disorders
- ClinicalTrials.gov ID
- NCT05566496
- Acronym / sponsor ID
- 201503062RIND
- Conditions
- Tourette Syndrome in Children
- Keywords
- MRI, pediatric neurology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Oct 2022 (actual)
- 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 findings of resting-state functional magnetic resonance imaging and diffusion spectrum imaging in subtypes of tics-related disorders
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourette | – | Diagnostic Test: Brain MRIAge less than 18 years old Diagnosed as Tourette syndrome or chronic tic disorders No other neuropsychiatric disorders |
| Healthy | – | Diagnostic Test: Brain MRIAge less than 18 years old No other neuropsychiatric disorders |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- We enrolled treatment-naive Tourette syndrome or chronic tic disorder pediatric patients for Tourette group and healthy age- and gender-matched participants for healthy control
Key inclusion criteria (2 listed)
- Age less than 18 years old
- Diagnosed as Tourette syndrome or chronic tic disorders
Key exclusion criteria (3 listed)
- History of neuropsychiatric disorders
- Already receive treatment for Tourette syndrome/chronic tics disorder
- Have some device not allowed for MRI scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRIAll participants receive brain MRI evaluation and clinical evaluation of tic severity. | Diagnostic test | Healthy, Tourette |
Primary outcome
Difference between healthy and Tourette group
Time frame: 2 years after enrollment for primary evaluation
Difference of MRI result between healthy and Tourette group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
Wang-Tso Lee principal investigator
National Taiwan University Children Hospital Pediatric neurology department
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 in Children, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: looking for participants now, as of the sponsor's last update on 6 Aug 2024. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang-Tso Lee ((886)2-23123456 ext. 71618, leeped@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between healthy and Tourette group (time frame: 2 years after enrollment for primary evaluation). 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 6 Aug 2024.