UMIN-CTR Clinical Trial

Basic information
Public title	Memory improvement by neuro-feedback method targeting sharp wave ripples
Acronym	Memory improvement by neuro-feedback method targeting sharp wave ripples
Scientific Title	Memory improvement by neuro-feedback method targeting sharp wave ripples
Scientific Title:Acronym	Memory improvement by neuro-feedback method targeting sharp wave ripples
Region	Japan

Condition
Condition	epilepsy
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Intracranial electrode implantation is commonly used as a preoperative examination for epilepsy to determine the extent of surgical resection. In this study, we will investigate how brain activity and neurological symptoms, especially memory, are altered by visual or auditory neurofeedback (NF) targeting sharp wave ripples (SWR) from hippocampal gyrus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correct response rate and reaction time of Sternberg memory test before and after neuro-feedback training
Key secondary outcomes	Duration, frequency, and amplitude of detected SWR

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Detect SWR in real-time from the subject's intracranial EEG. Auditory and visual feedback is presented to the subject based on the detected SWR. Subjects are trained to intentionally control the presented feedback. The experiment will be conducted under several conditions by changing the relationship between the detected SWR and the change in feedback. In this study, we will observe differences in the effects of neurofeedback under these different conditions. Subjects will be instructed to control visual and auditory feedback by thinking about something without moving their bodies. Feedback will be provided in two conditions, A and B. In A, the feedback will be in the direction that increases in proportion to the duration of the SWR, and in B, the feedback will be in the opposite direction. After each training session, a memory task is performed. Feedback A and B are performed on the same day whenever possible; the combined daily training time for A and B is approximately 1 hour. The two feedbacks should be continued if there is no fatigue or other adverse event. If fatigue or other adverse events prevent the two feedbacks from being conducted on the same day, they should be conducted on different days.
Interventions/Control_2	Detect SWR in real-time from the subject's intracranial EEG. Auditory and visual feedback is presented to the subject based on the detected SWR. Subjects are trained to intentionally control the presented feedback. The experiment will be conducted under several conditions by changing the relationship between the detected SWR and the change in feedback. In this study, we will observe differences in the effects of neurofeedback under these different conditions. Subjects will be instructed to control visual and auditory feedback by thinking about something without moving their bodies. Feedback will be provided in two conditions, A and B. In A, the feedback will be in the direction that increases in proportion to the duration of the SWR, and in B, the feedback will be in the opposite direction. After each training session, a memory task is performed. Feedback A and B are performed on the same day whenever possible; the combined daily training time for A and B is approximately 1 hour. The two feedbacks should be continued if there is no fatigue or other adverse event. If fatigue or other adverse events prevent the two feedbacks from being conducted on the same day, they should be conducted on different days.
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who have electrodes implanted around the hippocampus for clinical reasons Patients are at least 18 years old but less than 80 years old at the time of consent Patients have given written consent to participate in this study
Key exclusion criteria	Patients with significant cognitive impairment Patients deemed unsuitable by the principal investigator or subinvestigator
Target sample size	4

Research contact person
Name of lead principal investigator	1st name Takufumi Middle name Last name Yanagisawa
Organization	Osaka University Hospital
Division name	Neurosurgery
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka
TEL	0668793652
Email	tyanagisawa@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Takamitsu Middle name Last name Iwata
Organization	Osaka University Hospital
Division name	Neurosurgery
Zip code	565-0871
Address	2-15 Yamadaoka, Suita, Osaka
TEL	0668795111
Homepage URL
Email	t-iwata@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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	Osaka University Clinical Research Review Board
Address	2-2 Yamadaoka, Suita, Osaka, Osaka
Tel	06-6210-8296
Email	handai-nintei@hp-crc.med.osaka-u.ac.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

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 25 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	2022 Year 04 Month 22 Day
Date of IRB	2022 Year 04 Month 22 Day
Anticipated trial start date	2022 Year 04 Month 22 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 25 Day
Last modified on	2022 Year 04 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054233