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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036309
Receipt No. R000041334
Scientific Title Safety and Efficacy of Neurofeedback with Electroencephalographic Phase Synchrony Index for Stroke symptom (aphasia), single center open label trial
Date of disclosure of the study information 2019/03/27
Last modified on 2019/03/27

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Basic information
Public title Safety and Efficacy of Neurofeedback with Electroencephalographic Phase Synchrony Index for Stroke symptom (aphasia), single center open label trial
Acronym NEPSIS Trial
Scientific Title Safety and Efficacy of Neurofeedback with Electroencephalographic Phase Synchrony Index for Stroke symptom (aphasia), single center open label trial
Scientific Title:Acronym NEPSIS Trial
Region
Japan

Condition
Condition Stroke
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We have reported that specific regional EEG phase synchrony index (PSI) was correlated with corresponding post-stroke symptom (for example, the PSI between language areas and aphasia score). In addition, we found longitudinal change of the PSI was correlated with aphasia recovery.
The aim of this study is to confirm the safety and efficacy of neurofeedback with EEG PSI in patients with post-stroke aphasia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes of the aphasia score after neurofeedback
Key secondary outcomes 1.Changes of EEG PSI during neurofeedback
2.Changes of EEG PSI after neurofeedback
2.Correlation between changes of EEG PSI and changes of the aphasia score

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. First episode stroke
2. Presence of aphasia symptom
Key exclusion criteria 1. Patient who can not understand informed consent or participate in the study
2. Medical history of epilepsy or psychiatric or other neurological disorders
3. Contraindication to MRI measurement
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Miyai
Organization Morinomiya Hospital
Division name Neurorehabilitation Research Institute
Zip code 536-0025
Address 2-1-88 Morinomiya, Joto-ku, Osaka 536-0025, Japan
TEL 81-6-6969-0111
Email miyai@omichikai.or.jp

Public contact
Name of contact person
1st name Teiji
Middle name
Last name Kawano
Organization Morinomiya Hospital
Division name Neurorehabilitation Research Institute
Zip code 536-0025
Address 2-1-88 Morinomiya, Joto-ku, Osaka 536-0025, Japan
TEL 81-6-6969-0111
Homepage URL
Email kawano@omichikai.or.jp

Sponsor
Institute Morinomiya Hospital
Institute
Department

Funding Source
Organization TOYOTA Motor Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Rhythm-based Brain Information Processing Unit, RIKEN CBS-TOYOTA Collaboration Center, RIKEN Center for Brain Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization Omichi-kai Social Medical Corporation IRB
Address 2-1-88 Morinomiya, Joto-ku, Osaka 536-0025, Japan
Tel 81-6-6969-0111
Email yoshida@omichikai.or.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 試験実施施設名称
森之宮病院(大阪府)
Morinomiya Hospital (Osaka)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 27 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
2019 Year 03 Month 26 Day
Date of IRB
2014 Year 01 Month 08 Day
Anticipated trial start date
2019 Year 03 Month 27 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 09 Month 30 Day

Other
Other related information none

Management information
Registered date
2019 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041334

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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