UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040832 |
|---|---|
| Receipt number | R000046619 |
| Scientific Title | Neurofeedback using deep brain stimulation electrode for parkinson disease |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/06/19 17:18:07 |
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Basic information
Public title
Neurofeedback using deep brain stimulation electrode for parkinson disease
Acronym
NF for PD with DBS
Scientific Title
Neurofeedback using deep brain stimulation electrode for parkinson disease
Scientific Title:Acronym
NF for PD with DBS
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to reveal relationship between brain activities and the symptoms of Parkinson disease when a neurofeedback training was applied for them.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
alteration of brain activities
Key secondary outcomes
UPDRS scores
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
training with neurofeedback
Interventions/Control_2
other training with neurofeedback
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with age more than 20
Subjects obtained the consent
Subjects with Parkinson disease using deep brain stimulation device
Key exclusion criteria
The subjects who can not conduct the tasks
Subjects with severe illness
Subjects whom the experimenter think as in appropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takufumi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Osaka university
Division name
medical school
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3652
tyanagisawa@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takufumi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Osaka university
Division name
medical school
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3652
Homepage URL
tyanagisawa@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 19 | Day |
Last modified on
| 2020 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046619
