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CompletedNCT05358314HRV_DBUpdated Nov 29, 2023

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

An observational study in Heart Rate, Magnetic Resonance Imaging and Stress, Physiological, sponsored by University of Heidelberg Medical Center. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by University of Heidelberg Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
25
Ages
18 Years to 55 Years
Sex
All
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Study summary

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).

Read the 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.

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Conditions studied

  • Heart Rate
  • Magnetic Resonance Imaging
  • Stress, Physiological

Keywords

  • fmri
  • heart rate variability
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In context

Lead sponsor

University of Heidelberg Medical Center is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy participants

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
25 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Experimental fMRI task (Stress induction following paced breathing)

    Participants are instructed to breathe at a very low pace and then have to complete an arithmethic task designed to induce stress.

    Time frame: 30 minutes

  2. HRV reactivity during stress

    Heart Rate Variability is assessed during MRI scanning using plethysmography.

    Time frame: 30 minutes

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Study locations

1 site
  • University Hospital Heidelberg
    Heidelberg, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05358314
Lead sponsor
University of Heidelberg Medical Center
Responsible party
Joe Simon (Principal Investigator, University of Heidelberg Medical Center) — Principal investigator
First posted
May 3, 2022
Start date
Feb 1, 2022
Primary completion
Jun 1, 2023
Completion
Sep 1, 2023
Last update
Nov 29, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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