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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044698
Receipt No. R000050991
Scientific Title Evaluation of splint therapy for tics and comorbid symptoms in Tourette syndrome
Date of disclosure of the study information 2021/06/29
Last modified on 2021/06/29

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Basic information
Public title Splint treatment for Tourette syndrome
Acronym Mouthpiece treatment for Tourette syndrome
Scientific Title Evaluation of splint therapy for tics and comorbid symptoms in Tourette syndrome
Scientific Title:Acronym Evaluation of splint therapy for tics and comorbid symptoms in Tourette syndrome.
Region
Japan

Condition
Condition Tourette syndrome
Classification by specialty
Neurology Pediatrics Psychiatry
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of splint therapy for Tourette syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes YGTTS (Yale Global Tic Severity Scale-Japan)
Key secondary outcomes ADHD Rating Scale-IV (ADHD RS-IV)
Yale-Brown Obsessive Compulsive Scale (Y-BOCS or CY-BOCS for children)
STAI (State-Trait Anxiety Inventory)
SCAS (Spence Children's Anxiety Scale)

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Splint for Tourette syndrome
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
14 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Tourette patient with severe vocal tics
who can visit our clinic regularly
2. Above fourteen-year-old
3. Patient who can continue to put splint
4. Patient who can make splint
Key exclusion criteria 1. Tourette patient with severe vocal tics
who cannot visit our clinic regularly
2. Under the age of fourteen-year-old
3. Patient who cannot continue to put splint
4. Patient who is judged to be inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kyoko
Middle name
Last name Hoshino
Organization Segawa Memorial Neurological Clinic for Children
Division name Director
Zip code 101-0062
Address 2-8, Surugadai, kanda, Chiyoda-ku, Tokyo, Japan
TEL 03-3294-0371
Email hoshino@segawa-clinic.jp

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name Hoshino
Organization Segawa Memorial Neurological Clinic for Children
Division name Director
Zip code 101-0062
Address 2-8, Surugadai, kanda, Chiyoda-ku, Tokyo, Japan
TEL 03-3294-0371
Homepage URL
Email hoshino@segawa-clinic.jp

Sponsor
Institute Segawa Memorial Neurological Clinic for Children
Institute
Department

Funding Source
Organization MHLW(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor *Pediatric dentistry hospital, Nihon University school of dentistry
*Special Care Dentistry, Osaka University Dental Hospital
Department of Physiology
*Kobe University
Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization lnstitutional Review Board of Segawa Memorial Neurological Clinic for Children
Address 2-8, Surugadai, kanda, Chiyoda-ku, Tokyo, Japan
Tel 03-3294-0371
Email rinri@segawa-clinic.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 01 Month 15 Day
Date of IRB
2021 Year 01 Month 15 Day
Anticipated trial start date
2021 Year 01 Month 15 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 29 Day
Last modified on
2021 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050991

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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