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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021957
Receipt No. R000025100
Scientific Title The analysis of Deep Brain Stimulation Effects in Parkinson's disease by Optical Functional Brain Imaging
Date of disclosure of the study information 2016/04/18
Last modified on 2020/04/21

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Basic information
Public title The analysis of Deep Brain Stimulation Effects in Parkinson's disease by Optical Functional Brain Imaging
Acronym The analysis of Deep Brain Stimulation Effects in Parkinson's disease by Optical Functional Brain Imaging
Scientific Title The analysis of Deep Brain Stimulation Effects in Parkinson's disease by Optical Functional Brain Imaging
Scientific Title:Acronym The analysis of Deep Brain Stimulation Effects in Parkinson's disease by Optical Functional Brain Imaging
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect on brain activity in Parkinson's disease by medication treatment and/or Deep Brain Stimulation based on changes in local cerebral blood flow estimated by Near Infrared Spectroscopy (NIRS)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of brain activity estimated by NIRS before and after medication treatment and/or Deep Brain Stimulation
Key secondary outcomes *UPDRS Part 2
*UPDRS Part 3
*Schwab and England scale
*SF-36
*PDQ-39
*Adverse Event

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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with Parkinson's disease have signed an informed consent document that are willing to participate in the study
Key exclusion criteria 1.Patients who use artificial respiration, assisted breathing device and oxygen therapy or who are necessary to use them judged by investigators.
2.Patients who use an implantation device like a pacemaker.
3.Patients who have brain disorder including cerebral infarction or brain tumor.
4.Patients who have participated in other clinical study within 12 weeks before participation of this study.
Target sample size 20

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 Faculty of Medicine
Institute
Department

Funding Source
Organization 1. Japan Society for the Promotion of Science
2.The Uehara Memorial Foundation
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
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(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.frontiersin.org/articles/10.3389/fnhum.2016.00629/full
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
2016 Year 04 Month 03 Day
Date of IRB
2016 Year 04 Month 11 Day
Anticipated trial start date
2016 Year 04 Month 18 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2016 Year 04 Month 18 Day
Last modified on
2020 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025100

Research Plan
Registered date File name
2017/01/19 Morishita fNIRS 2016.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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