UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056458 |
|---|---|
| Receipt number | R000064477 |
| Scientific Title | Influence of sex differences considering menstrual cycle on late brain activity(after 100ms post-stimulation) |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/04/23 11:21:44 |
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Basic information
Public title
Influence of sex differences considering menstrual cycle on late brain activity(after 100ms post-stimulation)
Acronym
Influence of sex differences considering menstrual cycle on late brain activity(after 100ms post-stimulation)
Scientific Title
Influence of sex differences considering menstrual cycle on late brain activity(after 100ms post-stimulation)
Scientific Title:Acronym
Influence of sex differences considering menstrual cycle on late brain activity(after 100ms post-stimulation)
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, it has been pointed out that it is important to consider the menstrual cycle (sex hormones) when examining neurophysiological sex differences. It has been reported that estrogen (especially estradiol: E2) and progesterone (P4) play a major role in the female menstrual cycle and influence human brain function. However, very few studies have examined neurophysiological sex differences in terms of the menstrual cycle. Therefore, the purpose of this study is to investigate the effects of sex differences in menstrual cycle (especially menstrual and ovulatory phases) on late brain activity (after 100 ms after stimulus presentation) in humans, and to clarify sex differences in higher-level brain function. We will also provide evidence that it is important to consider menstrual cycle (sex hormones) and sex differences when examining neurophysiological sex differences.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In order to investigate the effect of sex difference on late brain activity (after 100 ms of stimulus presentation), we record somatosensory evoked potentials (SEPs) and auditory evoked potentials (AEPs) during simple response and resting conditions using electroencephalogram (EEG) and evaluate the sex difference. In this process, women are measured in two periods: the menstrual period and the ovulatory period. The menstrual period is defined as the period from the second to the fourth day after the onset of menstruation, and the ovulatory period is defined as the period from the second to the fourth day after a positive urine ovulation test. This allows for detailed clarification of sex differences in higher-order brain function. It also provides evidence that it is important to consider the menstrual cycle (sex hormones) and sex differences when examining neurophysiological sex differences.
Key secondary outcomes
Somatosensory evoked potentials (SEPs) and auditory evoked potentials (AEPs) during simple response and resting conditions will be recorded using electroencephalography (EEG) to evaluate differences in women's menstrual cycle periods. In this process, women will be measured in two periods: the menstrual cycle and the ovulatory cycle. The menstrual cycle is defined as the period from the second to the fourth day after the onset of menstruation, and the ovulatory cycle is defined as the period from the second to the fourth day after a positive urine ovulation test. This allows for detailed clarification of sex differences in higher-order brain function. It also provides evidence that it is important to consider the menstrual cycle (sex hormones) and sex differences when examining neurophysiological sex differences.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Electrical Stimulation
Auditory Stimulation
EEG
Interventions/Control_2
Electrical Stimulation
Auditory Stimulation
EEG
Interventions/Control_3
Electrical Stimulation
Auditory Stimulation
EEG
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Right-handed normal adult men and women
Females are normal menstruating adults (menstrual cycle of 28 to 35 days)
Adults with no history of psychiatric or neurological disorders
Key exclusion criteria
Adults with no history of psychiatric or neurological disorders
Women with irregular menstruation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Anazawa |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare Studies
Zip code
950-3198
Address
1398 shimami-cho, kita-ku, Niigata city
TEL
070-2029-1720
hwd24012@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Anazawa |
Organization
Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare Studies
Zip code
950-3198
Address
1398 shimami-cho, kita-ku, Niigata city
TEL
070-2029-1720
Homepage URL
hwd24012@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
Niigata 950-3198, Japan
Tel
025-257-4500
hwd24012@nuhw.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 | 12 | Month | 31 | 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
| 2024 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | 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 | 12 | Month | 13 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064477
