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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039780
Receipt No. R000045353
Scientific Title Analysis of brain activities and behavior for assessment of decision-making function prior to and following Deep Brain Stimulation for severe Tourette syndrome
Date of disclosure of the study information 2020/03/12
Last modified on 2020/03/12

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Basic information
Public title Analysis of brain activities and behavior prior to and following Deep Brain Stimulation for severe Tourette syndrome
Acronym Analysis of brain activities and behavior prior to and following Deep Brain Stimulation for severe Tourette syndrome
Scientific Title Analysis of brain activities and behavior for assessment of decision-making function prior to and following Deep Brain Stimulation for severe Tourette syndrome
Scientific Title:Acronym Analysis of brain activities and behavior for assessment of decision-making function prior to and following Deep Brain Stimulation for severe Tourette syndrome
Region
Japan

Condition
Condition Severe Tourette syndrome
Classification by specialty
Psychiatry Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify pathophysiology and brain function of Tourette syndrome. To assess how brain stimulation induces neuropsycological change using neuropsycholotigal testings and brain MRI. Also to identify factors associated with beneficial effects by deep brain stimulation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Resting state functional MRI
Key secondary outcomes Neuropsycological assessment data

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 Patients meet the approved study (approved number 2017M098) criteria.
The operation criteria are following,
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 movements over 35/50 points on YGTSS in principle. If a patient is life-threatening condition or has difficulty living by involuntary movements even though YGTSS score or treatment period don't meet the inclusion criteria, several clinical departments should discuss carefully and consider the patient's applicability to the surgery
7.More than minimum 6-month medication or psychological therapy failed to improve the symptoms or those were intolerant because of side effects.
8.Multiple departments including with psychiatry, neurosurgery, neurology and pediatrics departments (if the patient is a child) should discuss indication of surgery.
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 20

Research contact person
Name of lead principal investigator
1st name Tooru
Middle name
Last name Inoue
Organization Fukuoka University Hospital
Division name Department of Neurosurgery
Zip code 814-0180
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 Takashi
Middle name
Last name Morishita
Organization Fukuoka University Hospital
Division name Department of Neurosurgery
Zip code 814-0180
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 Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fukuoka University Medical Ethics Review Board
Address 7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
Tel 092-801-1011
Email fumed-ethics@fukuoka-u.ac.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 福岡大学病院(福岡)

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 12 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
2020 Year 02 Month 07 Day
Date of IRB
2020 Year 02 Month 06 Day
Anticipated trial start date
2020 Year 02 Month 10 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Identifying factors that predict beneficial treatment effects will enable patient selection for applicable treatment

Management information
Registered date
2020 Year 03 Month 12 Day
Last modified on
2020 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045353

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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