UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000034933