UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021957 |
|---|---|
| Receipt number | 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 16:14:45 |
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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
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 Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
