UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044698 |
|---|---|
| Receipt number | 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 | 2023/04/03 14:29:56 |
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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
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
hoshino@segawa-clinic.jp
Sponsor or person
Institute
Segawa Memorial Neurological Clinic for Children
Institute
Department
Personal name
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
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
Enrolling by invitation
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
| 2028 | 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
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
