Tokyo, Nov. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059757) titled 'Investigating the neural basis of interoceptive sensation and behavioral change using transcutaneous auricular vagus nerve stimulation (taVNS)' on Nov. 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Dose comparison

Primary Sponsor: Institute - National Center for Neurology and Psychiatry, National Institute of Mental Health

Condition: Condition - Healthy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study, which non-invasively stimulates the vagus nerve to modulate interoception, is twofold:

1) To examine whether the enhancement of interoception strengthens altruistic behavior, and to elucidate the underlying mechanism of this transformation, through the induction of neuroplasticity achieved by adding transcutaneous auricular Vagus Nerve Stimulation (taVNS) to cognitive training.

2) To clarify the neural basis by investigating changes in brain activity and structural connectivity resulting from the respective and interactive effects of the known taVNS intervention and conventional cognitive training intervention.

The future outlook of this research is to provide a novel approach that contributes to the alleviation of depression and anxiety symptoms. Specifically, by focusing on the effects of altruistic behavior on mental health and exploring the potential for interoception enhancement to promote such behavior, we aim to contribute to the development of new therapies. This study holds interdisciplinary significance, encompassing psychological, neuroscientific, and clinical medical perspectives. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Cognitive behavioral Training of Interoception: The interoception training task (approx. 30 minutes) using a PC program will be administered once daily for 5 consecutive days. Interventions/Control_2 - taVNS stimulation: 30 minutes of taVNS will be administered once daily for 5 consecutive days.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Individuals aged 18 to 59 years at the time of informed consent. 2) Healthy adults with no regular hospital visits or medication use. Key exclusion criteria - Behavioral Experiments Individuals with a cochlear implant, cardiac pacemaker, or implanted Vagus Nerve Stimulator (VNS). Individuals with an injury to the auricular area (ear). Individuals who have undergone a cerebrospinal fluid (CSF) shunt procedure. Individuals with a diagnosis of glaucoma. Smokers. Individuals with frequent cardiac arrhythmias. Individuals whose resting heart rate is consistently below 60 beats per minute (bpm).

MRI Experiments Individuals with a cochlear implant, cardiac pacemaker, or implanted VNS. Individuals for whom MRI scanning poses a certain risk (e.g., tattoos, permanent make-up/cosmetic tattoos, claustrophobia, or other metallic implants/devices). Individuals with an injury to the auricular area (ear). Individuals who have undergone a cerebrospinal fluid (CSF) shunt procedure. Individuals with a diagnosis of glaucoma. Smokers. Individuals with frequent cardiac arrhythmias. Individuals whose resting heart rate is consistently below 60 beats per minute (bpm). Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 05 Day Date of IRB - 2025 Year 06 Month 05 Day Anticipated trial start date - 2025 Year 11 Month 13 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=R000067399

Disclaimer: Curated by HT Syndication.