The Findings of Magnetic Resonance Imaging in Subtypes of... | NCT05566496

Studies
The Findings of Magnetic Resonance Imaging in Subtypes of Tics-related Disorders

NCT05566496

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Aug 6, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Tourette Syndrome in Children

Interventions

Brain MRI

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2015Actual

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Sep 30, 2022

First Submission Date that Met QC Criteria

Sep 30, 2022

First Posted Date

Oct 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2024

Last Update Posted Date

Aug 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The findings of resting-state functional magnetic resonance imaging and diffusion spectrum imaging in subtypes of tics-related disorders

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tourette		Age less than 18 years old Diagnosed as Tourette syndrome or chronic tic disorders No other neuropsychiatric disorders	Diagnostic Test: Brain MRI
Healthy		Age less than 18 years old No other neuropsychiatric disorders	Diagnostic Test: Brain MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brain MRI	Diagnostic Test	All participants receive brain MRI evaluation and clinical evaluation of tic severity.	Healthy Tourette

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference between healthy and Tourette group	Difference of MRI result between healthy and Tourette group	2 years after enrollment for primary evaluation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age less than 18 years old
Diagnosed as Tourette syndrome or chronic tic disorders

Exclusion Criteria:

History of neuropsychiatric disorders
Already receive treatment for Tourette syndrome/chronic tics disorder
Have some device not allowed for MRI scan

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wang-Tso Lee	Contact	(886)2-23123456	71618	leeped@hotmail.com

Overall Officials

Name	Affiliation	Role
Wang-Tso Lee	National Taiwan University Children Hospital Pediatric neurology department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Children Hospital Pediatric Neurology Department	Recruiting	Taipei		100	Taiwan