UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016467 |
|---|---|
| Receipt number | R000019048 |
| Scientific Title | Study for DBS programing based on local field potential from DBS lead during surgery in Parkinson disease |
| Date of disclosure of the study information | 2015/02/09 |
| Last modified on | 2024/02/14 10:05:26 |
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Basic information
Public title
Study for DBS programing based on local field potential from DBS lead during surgery in Parkinson disease
Acronym
DBS programing based on local field potential
Scientific Title
Study for DBS programing based on local field potential from DBS lead during surgery in Parkinson disease
Scientific Title:Acronym
DBS programing based on local field potential
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore more effective DBS programing based on local field potential in Parkinson disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison with the best stimulation parameter and local field potential analysis
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with Parkinson disease who undergo DBS surgery in Juntendo University Hospital
2. Patients who can understand informed consent.
Key exclusion criteria
Patients assessed by the investigator to be ineligible for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Umemura |
Organization
Juntendo University
Division name
Department of Research and Therapeutics for Movement Disorders
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
aumemura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Umemura |
Organization
Juntendo University
Division name
Department of Research and Therapeutics for Movement Disorders
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
Homepage URL
aumemura@juntendo.ac.jp
Sponsor or person
Institute
Department of Research and Therapeutics for Movement Disorders, Juntendo University
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1 Hongo, Bunkyo, Tokyo
Tel
03-3813-3111
rinri@juntendo.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
順天堂大学運動障害疾患病態研究治療講座 / Department of Research and Therapeutics for Movement Disorders, Juntendo University
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
0
Results
none
Results date posted
| 2024 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
not applicable
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Local field potential recorded in DBS surgery is analyzed and compared with the best stimulation parameter
Management information
Registered date
| 2015 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019048
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
