Tokyo, Sept. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062847) titled 'Invastigation of brain nerve-interoceptive response induced by different body perception in real and virtual space' 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 - None Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this research is to elucidate how the basic dynamics of brain nerves and visceral reactions that occur during human body recognition and perception/recognition of objects differ between virtual and real spaces. Basic objectives2 - Others

Intervention: Interventions/Control_1 - In order to make people aware of the environment in the virtual space, we use a 3D space with a laboratory, a 3D model of a virtual room, or the avatars and objects of ourselves and others (desks, chairs, etc.) that exist there. Visual information and natural sounds heard in the environment (such as the sound of something touching) are presented as auditory information on a computer display, HMD, speaker, or headphones. The material is brought into contact with one or several locations selected through experiments among the fingers, palms, backs of hands, arms, shoulders, backs, and feet. When creating a pseudo-tactile experience without contacting the material, a bone conduction speaker (SOUNDBONE, GD-SBM, Golden Dance) and a vibration stimulator (mini PTS system, Dancer Design, UK) are used.Moreover, 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 - Those who meet the following [research subject application conditions] -Healthy adults between 18 and 40 years old -Persons who can obtain written consent from the individual to participate in the research freely. -Those who have sufficient physical strength to sit and stand from a chair by themselves. -Persons with no history of cardiovascular disease such as stroke or ischemic heart disease. -Height: 145-190cm, weight: 90kg or less, hip width: 40cm or less (due to restrictions on equipment installation on the fMRI bed) -Handed hand: Right-handed (not corrected to be right-handed) (because brain reactions differ depending on the handedness). -Persons without hearing impairment. -Persons with no physical injuries (minor scratches, etc. may participate depending on the situation). -Persons who do not have any metal objects in their body, regardless of the material. (However, dental fillings and crowns are allowed. Implants are not allowed.) (Restrictions on fMRI imaging) -Persons who have never had head surgery. -Persons who do not have a history of claustrophobia or dark fear. (This is done in a closed room with the lights turned off) Key exclusion criteria - Those who meet any of the following [exclusion conditions for research subjects] are not eligible. [Not allowed] Women who are pregnant or may become pregnant [Not allowed] Those who cannot maintain the same posture for a long time due to hernia etc. [Not allowed] Those with a history of neuropathic symptoms such as sciatica. [Not allowed] Those who are taking medicine. (Cold medicine, medicines that control the function of neurotransmitters, etc.) [Not allowed] Persons with a history of neurological diseases including epilepsy. Target Size - 480

Recruitment Status: Recruitment status - Suspended Date of protocol fixation - 2023 Year 07 Month 28 Day Date of IRB - 2023 Year 12 Month 15 Day Anticipated trial start date - 2024 Year 04 Month 17 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059809

Disclaimer: Curated by HT Syndication.