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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05358314
Other study ID # S-070/2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date September 1, 2023

Study information

Verified date November 2023
Source University of Heidelberg Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Locations

Country Name City State
Germany University Hospital Heidelberg Heidelberg

Sponsors (2)

Lead Sponsor Collaborator
University of Heidelberg Medical Center University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 minutes
Primary HRV reactivity during stress Heart Rate Variability is assessed during MRI scanning using plethysmography. 30 minutes
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