UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047589 |
|---|---|
| Receipt number | R000054233 |
| Scientific Title | Memory improvement by neuro-feedback method targeting sharp wave ripples |
| Date of disclosure of the study information | 2022/04/25 |
| Last modified on | 2022/04/25 18:35:41 |
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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
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
t-iwata@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054233
