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Non-invasive nerve stimulation to study stomach-brain signals in depression

Tests a non-invasive vagus nerve stimulation device in adults with major depression.

Plain-language title generated from the registry record
Registry title: Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression

Key facts

Where
Bonn, GermanySee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

Source: NCT06389175, who can take part

Where in Germany

  • Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of BonnBonn, GermanyNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Bonn
Trial code
NCT06389175
Record updated
4 December 2024
Original description
The overarching goal of the project is to determine whether differences in stomach-brain coupling contribute to key symptoms of major depressive disorder (MDD) and whether transcutaneous non-invasive vagus nerve stimulation (tVNS) may serve as a non-invasive intervention to improve aberrant interoceptive signaling in participants suffering from MDD.Read full original descriptionShow less

Keeping Mind and Body in Sync: Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression

The overarching goal of the project is to determine whether differences in stomach-brain coupling contribute to key symptoms of major depressive disorder (MDD) and whether transcutaneous non-invasive vagus nerve stimulation (tVNS) may serve as a non-invasive intervention to improve aberrant interoceptive signaling in participants suffering from MDD.

Inclusion: Between 18 and 55 years of age; BMI between 18.5 and 30kg/m\^2; Legally valid declaration of consent; MDD group: current major depressive episode based on DSM V criteria.

Exclusion: Following diagnosis within 12 months before start of experiment: obsessive compulsive disorder, somatic symptom disorder, eating disorder; Contraindications for MRI (e.g. metal implants, claustrophobia) or tVNS (e.g. piercings, sore or diseased skin areas on the outer right ear); Current or past diagnosis of brain injury, epilepsy, schizophrenia, bipolar disorder, severe substance use disorder (exception: tobacco), coronary heart disease, stroke; Pregnant and breastfeeding women are not included; Unclear ability to give consent.

ClinicalTrials.gov NCT06389175