UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030592
Receipt number 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 16:05:15

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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 or person

Institute

Fukuoka University Hospital

Institute

Department

Personal name



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

Value
https://center6.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