UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060086 |
|---|---|
| Receipt number | R000068699 |
| Scientific Title | A Multimodal Investigation into the Neural Mechanisms Linking Respiratory Interoception with Emotional and Pain Perception |
| Date of disclosure of the study information | 2025/12/16 |
| Last modified on | 2025/12/15 13:24:10 |
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Basic information
Public title
A Comprehensive Study on the Link Between Breathing Sensations, Emotions, and Pain, and Their Brain Mechanisms
Acronym
Investigating the Brain Mechanisms of Breathing, Emotions, and Pain
Scientific Title
A Multimodal Investigation into the Neural Mechanisms Linking Respiratory Interoception with Emotional and Pain Perception
Scientific Title:Acronym
Elucidating the Neural Basis of the Relationship Between Respiratory Interoception, Emotion, and Pain
Region
| Japan |
Condition
Condition
chronic pain, affective disorder
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of Respiratory Interoception: Task Accuracy and Subjective Evaluations
Key secondary outcomes
Neural activity data: EEG, MRI
Assessment of pain perception: Heat and cold pain thresholds, heat and cold pain tolerance thresholds
Emotion-related questionnaires: Pain-related measures (PCS, PVAQ, TSK), depression (BDI), anxiety (STAI), alexithymia (TAS), interoception (MAIA, IAS-J, IATS-J)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
transcranial electrical stimulation: real, washout 1 week, sham
Interventions/Control_2
transcranial electrical stimulation: sham, washout 1 week, real
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 27 | 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 sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Koshi |
| Middle name | |
| Last name | Iimuro |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-Cho, Kita-Ku, Niigata City, Niigata
TEL
025-257-4448
hwd25001@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Koshi |
| Middle name | |
| Last name | Iimuro |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-Cho, Kita-Ku, Niigata City, Niigata
TEL
025-257-4448
Homepage URL
hwd25001@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-Cho, Kita-Ku, Niigata City, Niigata
Tel
025-257-4448
hwd25001@nuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 15 | Day |
Last modified on
| 2025 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068699
