UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of neurofeedback therapy for mild cognitive impairement
Title of the study (Brief title)	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	Shigeru Morinobu
Organization	Kochi University
Division name	Dept. Neuropsychiatry, Sch. Med.
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	0888802359
Email	smorinob@kochi-u.ac.jp

Public contact
Name of contact person	Shigeru Morinobu
Organization	Kochi University
Division name	Dept. Neuropsychiatry, Sch. Med.
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	0888802359
Homepage URL	https://neuropsychiatry.kochi.univ/
Email	smorinob@kochi-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, KOchi Medical School, KOchi University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026756