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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030592
Receipt No. R000034933
Scientific Title Prospective survey of efficacy and safety of Deep Brain Stimulation for severe involuntary movement in Tourette syndrome
Date of disclosure of the study information 2017/12/27
Last modified on 2019/07/01

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Basic information
Public title Prospective survey of efficacy and safety of Deep Brain Stimulation for severe involuntary movement in Tourette syndrome
Acronym Prospective survey of Deep Brain Stimulation for severe involuntary movement in Tourette syndrome
Scientific Title Prospective survey of efficacy and safety of Deep Brain Stimulation for severe involuntary movement in Tourette syndrome
Scientific Title:Acronym Prospective survey of Deep Brain Stimulation for severe involuntary movement in Tourette syndrome
Region
Japan

Condition
Condition Patients with severe involuntary movement in Tourette syndrome
Classification by specialty
Psychiatry Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study prospectively long- and medium-term effects of DBS in patients with severe involuntary movement in Tourette syndrome which is rare disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes YGTSS(Yale Global Tic Severity Scale)
Key secondary outcomes Modified Rush Tic Rating Scale, Yale-Brown Obsessive-Compulsive Score, neuropsychological test(WAIS-3,WMS-R,BD1-2,MMPI), Cortical activities measured by NIRS

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with Dystonic tic who are to undergo DBS covered by national Health Care Insurance System
2.Patients over 12 years old.
If patients under 12 years old are applicable to the surgery of severe involuntary movement, medical ethical committee will deliberate it.
3.Patients signed an informed consent document.
4.Patient's legal representatives sign an informed consent document if patients are minor.
5.Patients meet DSM-4 for clinical diagnose criteria of Tourette syndrome
6.Patients with severe involuntary movement meet over 35/50 in YGTSS.
7.More than 6 months medication or psychological therapy failed to improve the symptoms or those were intolerant because of side effects.
8.If patients are life-threatening condition by involuntary movements even though YGTSS sore or treatment period or so don't meet inclusion criteria, they are to undergo the surgery after approval by medical ethical committees.
Key exclusion criteria 1.High risk patients with physical or mental complications (severe cardiovascular disorder, severe respiratory dysfunction, severe blood diseases, epilepsy, medical history of severe head injuries, severe stroke, severe neurodegenerative diseases, autism, schizophrenic, manic depression, drug addictions, pregnant, breast-feeding, female patients of child-bearing potential
2.Patients ineligible to the study based on investigator's decision.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tooru Inoue
Organization Fukuoka University Hospital
Division name Department of Neurosurgery
Zip code
Address 7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL 092-801-1011
Email toinoue@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Morishita
Organization Fukuoka University Hospital
Division name Department of Neurosurgery
Zip code
Address 7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL 092-801-1011
Homepage URL
Email tmorishita@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Hospital
Institute
Department

Funding Source
Organization Fukuoka University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福岡大学病院 Fukuoka University Hospital

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 27 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective survey

Management information
Registered date
2017 Year 12 Month 27 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034933

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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