UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023571 |
|---|---|
| Receipt number | R000026756 |
| Scientific Title | Development of neurofeedback therapy for mild cognitive impairement |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2016/08/09 20:24:59 |
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Basic information
Public title
Development of neurofeedback therapy for mild cognitive impairement
Acronym
MCI and neurofeedback
Scientific Title
Development of neurofeedback therapy for mild cognitive impairement
Scientific Title:Acronym
MCI and neurofeedback
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of neurofedback therapy using fMRI for patinets with MCI to improve the cognitive dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of total scores of WAIS-III before and after neurofeedback treapy
(Neurofeedback 10 min/day, 5 times/week, Total 20 times)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Neurofeedback using fMRI (10 min/day, 5 times/week, Total 20 times)
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
Persons having the total scores of Mini Mental State Examination equal to or more than 23.
Persons having the memory disturbance subjectively and objectively.
Key exclusion criteria
Patients with Dementia
Patients with organic brain disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Morinobu |
Organization
Kochi University
Division name
Dept. Neuropsychiatry, Sch. Med.
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
0888802359
smorinob@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Morinobu |
Organization
Kochi University
Division name
Dept. Neuropsychiatry, Sch. Med.
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
0888802359
Homepage URL
https://neuropsychiatry.kochi.univ/
smorinob@kochi-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, KOchi Medical School, KOchi University
Institute
Department
Personal name
Funding Source
Organization
Department of Neuropsychiatry, Kochi Medical School, Kochi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kochi Institute of Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
高知大学医学部付属病院（高知県）
高知工科大学（高知県）
Other administrative information
Date of disclosure of the study information
| 2016 | 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
| 2016 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 09 | Day |
Last modified on
| 2016 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026756
