Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059680) titled 'Effects of Different Stimulation Intensities of Transcutaneous Auricular Vagus Nerve Stimulation on Changes in the Functional State of the Locus Coeruleus-Noradrenaline System During Cognitive Activity: A Single-Blind Randomized Controlled Trial' on Feb. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants 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 - This study aims to investigate whether cognitive performance and the functional state of the locus coeruleus-norepinephrine differ among three groups classified by a single-blind randomized controlled trial: a group receiving stimulation at an intensity set by the threshold method, a group receiving stimulation at 0.5 mA, and a control group receiving no stimulation.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Individually adjusted intensity transcutaneous auricular vagus nerve stimulation
Interventions/Control_2 - Transcutaneous auricular vagus nerve stimulation at 0.5mA intensity
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Native language is Japanese
Right-handed
Key exclusion criteria - History of epileptic seizures or family history
Presence of neurological, psychiatric, or cardiac disorders
History of external ear trauma
Presence of internal implants
Regular use of medications
Pregnancy
Alcohol or drug dependence
Target Size - 42
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 01 Day
Anticipated trial start date - 2026 Year 02 Month 01 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=R000068266
Disclaimer: Curated by HT Syndication.
