The Brain-Heart-Gut Connection

Launched by UNIVERSITY OF BERN · Dec 20, 2024

Keywords

ClinConnect Summary

The clinical trial titled "The Brain-Heart-Gut Connection" is studying how the brain, heart, and gut work together, especially in people with major depression and related symptoms like digestive issues. The researchers want to improve treatments for major depressive disorder (MDD) by using a method called repetitive transcranial magnetic stimulation (rTMS) to target specific areas of the brain. They are particularly interested in personalizing this treatment by measuring heart rate responses and other bodily signals to find the best ways to help each individual.

To participate in this trial, you need to be between 18 and 65 years old. In the first group, healthy individuals will be included, while the second group will consist of people with symptoms of depression and autonomic dysfunction, which affects how the body controls automatic functions like heart rate and digestion. Participants will undergo tests that include brain mapping and monitoring heart and gut responses during treatment sessions. The goal is to gather valuable information to create more effective and individualized treatment options for those struggling with depression and related conditions.

Gender

ALL

Eligibility criteria

• • In study arm 1, all participants are healthy between 18 and 65 years of age, and able to give written informed consent.
• In study arm 2, all participants must be between 18 and 65 years of age and additionally fulfill the following criteria:
• • Elevated autonomic symptom score (\> 20) on the Composite Autonomic Symptom Score
• • Depressive symptoms indicated by an elevated score (\>5) in the Patient Health Care Questionnaire (PHQ-9?) or elevated scores (\>9) in the Depression Anxiety and Stress Scale (DASS).
• • Elevated Score on Selected questions of the Subchapter "symptoms in the Stomach or Intestines" of the "Rome IV Diagnostic Questionnaire for Adult Functional Gastrointestinal Disorders (Drossman, D. A. (Ed.). (2016). Rome IV: Functional Gastrointestinal Disorders - Disorders of Gut-Brain Interaction (4th ed.). Rome Foundation)
• For both arms, the following criteria must be fulfilled:
• • Normal or corrected-to-normal vision and hearing.
• • Willingness to participate and signed informed consent
• • No Medication with cognitive side effects (e.g. psychoactive medications or sleeping pills) or medication affecting gastric motility
• • No ectopic heartbeat
• • No history of epilepsy or seizure
• • No metal implants or devices (e.g. cardiac pacemakers)
• • No substance abuse or recent drug consumption
• • No pregnancy
• • No history of brain- heart- or gastrointestinal surgery
• • No skin conditions
• • BMI \<30