UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036309 |
|---|---|
| Receipt number | 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 | 2024/04/18 15:16:13 |
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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
miyai@omichikai.or.jp
Public contact
Name of contact person
| 1st name | Misako |
| Middle name | |
| Last name | Miyata |
Organization
Morinomiya Hospital
Division name
Secretariat
Zip code
536-0025
Address
2-1-88 Morinomiya, Joto-ku, Osaka 536-0025, Japan
TEL
81-6-6969-0111
Homepage URL
miyata@omichikai.or.jp
Sponsor or person
Institute
Morinomiya Hospital
Institute
Department
Personal name
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
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
Terminated
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
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041334
