Investigating Neuronal and Peripheral Markers of Brain Heart Interaction in Healthy Participants Under Stress (HRV_DB)

November 28, 2023 updated by: Joe Simon, University of Heidelberg Medical Center
This study seeks to investigate which regions of the brain are relevant in the regulation of cardiac control and how the interplay between HRV and those regions change during different physiological states (stress versus relaxation). In order to achieve this, we will use functional magnetic resonance imaging (fMRI) during an experimental task consisting of deep breathing and a psychosocial stress task (Montreal Imaging Stress Task).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Heart rate variability (HRV) is an important indicator of an organism's ability to adapt and regulate autonomic cardiac function. High heart rate variability is an indicator of good adaptability to physical and mental demands, while decreased HRV is associated with increased vulnerability to psychological and physical stressors. Previous studies have shown that the central autonomic network, composed of several regions of the brain such as the amygdala and prefrontal cortex, play an important role in regulating heart rate variability. However, the exact neural correlates and underlying neural mechanisms involved in autonomic cardiac control are still a subject of investigation. Furthermore, the dynamic connectivity between heart rate variability and the central autonomic network under changing physiological circumstances remains largely unexplored. This study seeks to investigate which regions of the brain are especially relevant in the regulation of cardiac control and how the interplay between HRV and those regions change during different physiological states (stress versus relaxation). In order to achieve this, we will use functional magnetic resonance imaging (fMRI) during an experimental task consisting of deep breathing and a psychosocial stress task (Montreal Imaging Stress Task). This paradigm will allow assessing the dynamic interplay between the heart and the brain. 30 healthy participants will be recruited, in addition to fMRI scanning participants will perform a psychometric test battery. A better understanding of these psychobiological mechanisms is a fundamental requirement for a better understanding of the autonomic regulation of HRV and the development of improved treatment strategies for disorders characterized by an impaired autonomic system and reduced HRV.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany
        • University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy participants

Description

Inclusion Criteria:

  1. Over age of 18 years.
  2. Right-handedness.
  3. Normal or corrected-to-normal vision.

Exclusion Criteria:

  1. History of head injury or surgery
  2. History of neurological disorder
  3. Severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse)
  4. Smoking
  5. Borderline personality disorder
  6. Current psychotropic medication
  7. Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers)
  8. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Experimental fMRI task (Stress induction following paced breathing)
Time Frame: 30 minutes
Participants are instructed to breathe at a very low pace and then have to complete an arithmethic task designed to induce stress.
30 minutes
HRV reactivity during stress
Time Frame: 30 minutes
Heart Rate Variability is assessed during MRI scanning using plethysmography.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Heidelberg Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-070/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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