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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032937
Receipt No. R000037550
Scientific Title Neurofeedback for Parkinson diseases
Date of disclosure of the study information 2019/01/01
Last modified on 2018/06/10

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Basic information
Public title Neurofeedback for Parkinson diseases
Acronym NF for PD
Scientific Title Neurofeedback for Parkinson diseases
Scientific Title:Acronym NF for PD
Region
Japan

Condition
Condition Parkinson disease
Classification by specialty
Neurology Adult
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 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes alteration of brain activities
Key secondary outcomes UPDRS scores

Base
Study type Interventional

Study design
Basic design Cross-over
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 Prevention
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Subjects with age more than 20
Subjects obtained the consent
Subjects with Parkinson disease and healthy subjects
Key exclusion criteria The subjects who can not conduct the tasks
Subjects with severe illness
Subjects whom the experimenter think as in appropriate
subjects with implantable devices such as pacemaker
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takufumi Yanagisawa
Organization Osaka university
Division name medical school
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3652
Email tyanagisawa@nsurg.med.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takufumi yanagisawa
Organization Osaka University
Division name medical school
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3652
Homepage URL
Email tyanagisawa@nsurg.med.osaka-u.ac.jp

Sponsor
Institute AMED
Institute
Department

Funding Source
Organization AMED
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

Other administrative information
Date of disclosure of the study information
2019 Year 01 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
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 10 Day
Last modified on
2018 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037550

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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