UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039780 |
|---|---|
| Receipt number | 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 09:07:26 |
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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
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
tmorishita@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045353
