UMIN-CTR Clinical Trial

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