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
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
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
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
