NCT06389175Enrolling by invitation
Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression
Keeping Mind and Body in Sync: Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 24 Apr 2024
- Start date
- 21 May 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Bonn
- Diseases
- Depression
- NCT number
- NCT06389175
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 21 May 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Current or past diagnosis of brain injury, epilepsy, schizophrenia, bipolar disorder, severe substance use disorder (exception: tobacco), coronary heart disease, stroke
Other
- Pregnant and breastfeeding women are not included
- Unclear ability to give consent
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Section of Medical Psychology, Department of Psychiatry & Psychotherapy, Faculty of Medicine, University of Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.