Tokyo, Sept. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062844) titled 'Investigation of brain responses related to physical sensations accompanied by mild pain stimuli' on Sept. 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - National Institute of Advanced Industrial Science and Technology (AIST)
Condition:
Condition - Not for specific disiease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In this study, (1) for healthy adult participants, (2) selective stimulation of nerve fibers to extract brain responses corresponding to specific fiber-related tactile comforts. The purpose of this study is to clarify whether (3) compairing to non nerve-fiber-specific stimulation, (4) specific waveforms can be found at specific latency and specific scalp site.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Using peripheral nerve electrical stimulator (PNS-5100; Japan manufactured by Koden) and its stimulation electrode (NM-983W; Using Japan manufactured by Kodensha), epidermal electric stimulations are delivered to participants.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - -Healthy adults between 18 and 40 years old
-Those who can obtain written consent from the individual to participate in the research voluntarily.
-Those who are physically strong enough to stand and sit on a chair by themselves.
-People who have no history of cardiovascular disease such as stroke or ischemic heart disease.
-Height: 145-190cm, Weight: 90kg or less, Waist width: 40cm or less
-Handedness: Right-handed (those who have been corrected to be right-handed are not allowed).
-Those who have no hearing impairment.
-Those who have no injury to the body, mainly the left hand and left arm.
-Those who do not have any metal objects in their body, regardless of the material. (However, tooth fillings and crowns are permitted. Implants are not permitted.)
-Those who have never undergone head surgery.
-Those who do not have a history of claustrophobia or phobia of the dark.
Key exclusion criteria - -[Not allowed] Those who are pregnant or may be pregnant
-[Not allowed] Those who cannot maintain the same posture for a long time due to hernia.
-[Not allowed] Those who are taking medicine. (Cold medicines, medicines that control the function of neurotransmitters, etc.)
-[Not allowed] Those who are allergic to alcohol
Target Size - 120
Recruitment Status:
Recruitment status - Suspended
Date of protocol fixation - 2025 Year 09 Month 01 Day
Date of IRB - 2023 Year 08 Month 10 Day
Anticipated trial start date - 2025 Year 11 Month 28 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058548
Disclaimer: Curated by HT Syndication.