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OpenTrials
Completed

NCT Number: NCT05358314

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

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).

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Heidelberg

Heidelberg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over age of 18 years.
  • Right-handedness.
  • Normal or corrected-to-normal vision.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. HRV reactivity during stress

    Time frame: 30 minutes

    Heart Rate Variability is assessed during MRI scanning using plethysmography.

Sponsors and collaborators

Lead sponsor

University of Heidelberg Medical Center

Other

Collaborators

  • University of Cologne

Registry information

Acronym: HRV_DB

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 3, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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