UMIN-ICDS Clinical Trial

Public title

The Influence of Cardiodynamics on the Sense of Agency

Acronym

The Influence of Cardiodynamics on the Sense of Agency

Scientific Title

The Influence of Cardiodynamics on the Sense of Agency

Scientific Title:Acronym

The Influence of Cardiodynamics on the Sense of Agency

Region

Japan

Condition

Healthy individuals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Investigating how cardiovascular dynamics influence the sense of agency

Basic objectives2

Others

Basic objectives -Others

Investigating how cardiac interoception influences the sense of agency

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

How performance on a sense-of-agency task is influenced by cardiovascular dynamics and cardiac interoception

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy right-handed individuals aged 18 years or older.
Individuals who self-report no current physical, neurological, or psychiatric disorders that would interfere with study participation.
Individuals who have provided written informed consent after understanding the content of this study.

Key exclusion criteria

Individuals judged by the investigators to have difficulty understanding or performing the assessments and tests conducted in this study.
Individuals who regularly take medications that may affect heart rate, blood pressure, autonomic function, or central nervous system function.
Any other individuals judged by the investigators to be unsuitable for participation in this study.

Target sample size

40

Name of lead principal investigator

1st name	Yuri
Middle name
Last name	Terasawa

Organization

Faculty of Letters, Keio University

Division name

Department of Psychology

Zip code

223-8521

Address

4-1-1 Hiyoshi, kouhoku-ku, Yokohama-city

TEL

0455661366

Email

terasawa@flet.keio.ac.jp

Name of contact person

1st name	Yuri
Middle name
Last name	Terasawa

Organization

Faculty of Letters, Keio University

Division name

Department of Psychology

Zip code

223-8521

Address

4-1-1 Hiyoshi, kouhoku-ku, Yokohama-city

TEL

0455661366

Homepage URL

Email

terasawa@flet.keio.ac.jp

Institute

Keio University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Faculty of Letters, Keio University

Address

4-1-1 Hiyoshi, kouhoku-ku, Yokohama-city

Tel

0455661366

Email

flet-rec-office-group@keio.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

22

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

12

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

A cross-sectional study of healthy participants. Participants will perform an agency task and an interoception task, both with electrocardiographic (ECG) recording. We will evaluate how cardiovascular (hemodynamic) measures and interoception task performance relate to the sense of agency measured by the agency task. We will also collect basic variables, including participants' age, sex, and pulse rate. The following questionnaires will be used: the Generalized Anxiety Disorder-7 (GAD-7) for anxiety; the Patient Health Questionnaire-9 (PHQ-9) for depression; the Body Perception Questionnaire-Body Awareness Very Short Form (BPQ-BA) for bodily awareness; the Auditory Hallucination-like Experience Scale (AHES) for auditory hallucination-like experiences in healthy individuals; the Peters et al. Delusions Inventory (PDI) for delusion-like experiences in healthy individuals; the Toronto Alexithymia Scale (TAS) for alexithymia; the Sense of Agency Scale (SoAS) for sense of agency; and the Cambridge Depersonalisation Scale (CDS) for depersonalization symptoms.

Registered date

2026

Year

11

Month

10

Day

Last modified on

2026

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072700