UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053938 |
|---|---|
| Receipt number | R000061563 |
| Scientific Title | Time-dependent neural arbitration of stress memories |
| Date of disclosure of the study information | 2024/03/25 |
| Last modified on | 2025/03/07 17:50:33 |
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Basic information
Public title
Time-dependent neural arbitration of stress memories
Acronym
Time-dependent neural arbitration of stress memories
Scientific Title
Time-dependent neural arbitration of stress memories
Scientific Title:Acronym
Time-dependent neural arbitration of stress memories
Region
| Japan |
Condition
Condition
Post-traumatic stress disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigate the effects of mild psychological stressors, such as videos and audio clips, on individuals with intracranial electrodes. We measure intracranial brain waves in the hippocampus, amygdala, and frontal lobe, as well as physiological responses such as skin conductance. Additionally, we examine blood and saliva for hormonal levels and biochemical data. This research aims to explore how brain activity and biological responses related to stress memory change under these conditions. Concurrently, we also study changes in hormonal values and biochemical data in blood and saliva. By elucidating the neural responses, hormonal changes, and metabolic variations associated with stress responses in the brain, this study is expected to contribute to the diagnosis and treatment of neuropsychiatric disorders such as PTSD.
Basic objectives2
Others
Basic objectives -Others
We record intracranial brain waves in the hippocampus, frontal lobe, and amygdala at the time of stimulus exposure and the following day, identifying features such as sharp wave ripples (SWRs). Through this, we analyze functional connectivity within the brain and interpret brain information. This allows us to evaluate changes in brain waves resulting from the stimulus.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We analyze the relationship between the duration, frequency, and amplitude of waveforms such as sharp wave ripples (SWRs), and the results of thought content surveys, as well as physiological responses like skin conductance, pulse rate, and respiration, using regression analysis and other statistical methods.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants are asked to pay attention to audio, still images, and videos, lasting approximately 1 to 5 minutes, played on a monitor or through VR playback devices. During this, we measure intracranial brain waves, skin conductance, and monitor pulse and respiration using wearable devices and sensors. The videos and images may depict mildly stressful scenarios, such as traffic accidents, and may include sudden loud noises. The initial viewing of stress-inducing content occurs on Day 0, followed by a similar viewing on Day 1, and again between Day 3 and Day 5. Measurements of brain waves, skin conductance, pulse, and respiration are taken during these viewings to observe the persistence of stress memory.
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ndividuals who have electrodes placed around the hippocampus or amygdala for clinical reasons.
Those who are between the ages of 18 and under 50 at the time of consent.
Participants who have provided written consent to participate in the study.
Patients who are capable of giving consent themselves after receiving explanations through oral, written, or video formats.
Key exclusion criteria
Patients with significant cognitive impairments.
Patients currently undergoing treatment for any psychiatric disorder, those undergoing treatment for or with a history of PTSD, and individuals with a strong aversion to severe accidents such as traffic accidents.
Others deemed unsuitable by the principal investigator or co-investigators of the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takufumi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Osaka University
Division name
Neurosurgery
Zip code
565-0871
Address
2-2 Yamadaoka Suita-city Osaka
TEL
0668795111
tyanagisawa@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takufumi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Osaka University
Division name
Neurosurgery
Zip code
565-0871
Address
2-2 Yamadaoka Suita-city Osaka
TEL
06-6879-5111
Homepage URL
tyanagisawa@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Others
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 Hospital Institutional Review Board
Address
2-2 Yamadaoka Suita-city Osaka
Tel
06-6210-8296
rinri@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
| 2024 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061563
