Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058420) titled 'Sex difference in sensory gating with consideration of the menstrual cycle' on July 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Niigata University of Health and Welfare
Condition:
Condition - healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Sensory gating is a mechanism by which the brain selected sensory information processes and is an essential function for human survival. This function has been primary investigated using the P50 component of auditory evoked potentials (AEPs), and a reduction in the amplitude of the P50 has been reported in patients with schizophrenia. In other ward, patients with schizophrenia indicating impaired sensory gating compared to health groups. On the other hand, a study examining the relationship between gating in middle latency evoke potentials across somatosensory and auditory modalities in 20 healthy males suggested that early sensory gating level may be specific modality. However, influences by the menstrual cycle has not been clearly in previous studies. In our previous studies, we measured late activities of somatosensory and auditory evoked potentials following the P50 amplitude, examined their relationship with the menstrual cycle and sex differences. The results suggested that influence by the menstrual cycle on the sensory information processing may be differ depending on the modalities. Therefore, the present study aimed to investigate whether sex differences taking the menstrual cycle into account affect early sensory processing (i.e., sensory gating), which occurs prior to the late-phase activities.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Electrical Stimulation
Auditory Stimulation
EEG
Interventions/Control_2 - Electrical Stimulation
Auditory Stimulation
EEG
Eligibility:
Age-lower limit - 18
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 Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 21 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2026 Year 08 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066775
Disclaimer: Curated by HT Syndication.
