Tokyo, Dec. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060086) titled 'A Comprehensive Study on the Link Between Breathing Sensations, Emotions, and Pain, and Their Brain Mechanisms' on Dec. 16.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Niigata University of Health and Welfare
Condition:
Condition - chronic pain, affective disorder
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to elucidate the mechanisms underlying the relationship between respiratory interoception and emotional and pain perception. Specifically, we will quantify respiratory interoceptive processes using multiple objective and subjective indices, including inspiratory load discrimination performance, tolerance to breathlessness (breath-hold task), and metacognitive metrics such as confidence ratings. We will then examine how these respiratory interoceptive measures relate to emotional and pain perception. Furthermore, by acquiring electroencephalography (EEG) and magnetic resonance imaging (MRI) data during task performance, we will identify brain regions specifically involved in respiratory interoceptive processing. Finally, by applying non-invasive brain stimulation to these regions, we will investigate the neural mechanisms that contribute to respiratory interoception as well as to emotional and pain perception.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - transcranial electrical stimulation: real, washout 1 week, sham
Interventions/Control_2 - transcranial electrical stimulation: sham, washout 1 week, real
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Individuals aged 18 years or older who voluntarily expressed willingness to participate after receiving an explanation of the study.
Key exclusion criteria - Presence of a cardiac pacemaker; implantation of a metal plate near the stimulation site; a history of neurological disorders (including peripheral or central nervous system disorders) or respiratory diseases; current use of medications that affect brain function; and consumption of alcohol, caffeine, or tobacco within 24 hours prior to the experiment.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 12 Day
Anticipated trial start date - 2025 Year 12 Month 16 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=R000068699
Disclaimer: Curated by HT Syndication.