- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05358314
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
Completed
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
Observational
Enrollment (Actual)
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
-
-
-
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
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:
- 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
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
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.
Collaborators
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)
February 1, 2022
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
March 28, 2022
First Submitted That Met QC Criteria
May 2, 2022
First Posted (Actual)
May 3, 2022
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID 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.
Clinical Trials on Stress, Physiological
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
-
University of UtahEnrolling by invitation
-
Ohio State UniversityCompletedStress, PhysiologicalUnited States
-
Pennington Biomedical Research CenterCompleted
-
University of Wisconsin, MadisonCompleted
-
Centre Hospitalier Universitaire de NiceCompletedStress, Physiological
-
Texas State UniversityM. Hunter Martaindale; C. Dillard; D. GonzalezCompleted
-
Medical College of WisconsinNational Cancer Institute (NCI); National Heart, Lung, and Blood Institute... and other collaboratorsCompletedPhysiological StressUnited States
-
The University of Texas Health Science Center at...RecruitingStress, Physiological | Resilience, PsychologicalUnited States
-
Pontificia Universidad Catolica de ChileWithdrawnStress, Physiological | Surgery | AnesthesiaChile