🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression

RecruitingNAAges 18 Years - 65 YearsAllMax-Planck-Institute of Psychiatry
NCT07022171 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

Invasive vagus nerve stimulation (VNS) is an approved treatment of treatment-resistant depression (TRD) in Europe and in USA. Because of the associated possible surgical complications as well as side effects, invasive VNS is applied limitedly in the treatment of depression. Transcutaneous auricular VNS (tVNS), on the other hand, is a non-invasive alternative to traditional invasive VNS. tVNS is still considered an experimental treatment for depression. This is due to the limited high-quality evidence from randomized clinical studies, the not yet fully understood biological mechanisms of action, along with overall limited knowledge about the optimal stimulation parameters. To address these issues, the AddVNS study was initiated. The AddVNS study intends to recruit n=86 patients of the Max Planck Institute of Psychiatry with depression. The patients participating in the AddVNS study are go

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: 1. age 18-65 years, legally competent and able to provide informed consent; 2. diagnosis of a depressive episode (MDD or bipolar disorder) according to DSM 4/DSM 5 or ICD-10/ICD-11; 3. signed informed consent documents for the AddVNS study; 4. signed informed consent and participation in the biobanking project of MPIP; 5. use of a safe contraceptive method Exclusion Criteria: 1. age \< 18 years or age \> 65 years; 2. pregnancy or planning to get pregnant during the study period, breastfeeding; 3. legal supervision; 4. pervasive developmental disorders and/or intellectual disability; 5. acute substance abuse (e.g., alcohol, prescription or illicit drugs); 6. severe neurological disease; 7. technically or anatomically not possible tVNS (e.g., microtia or anotia, vagotomy); 8. current treatment with an established neurostimulation method (e.g., ECT, rTMS, VNS); 9. metallic foreign bodies, implanted intracranial devices or cerebral shunts; 10. severe general illness (e.g., relevant anemia requiring transfusion, high-grade cardiac arrythmia, severe cardiomyopathy); 11. active implants (e.g., cochlear implant, cardiac pacemaker, implantable cardioverter-defibrillator)
💊

What it tests

  • transcutaneous auricular vagus nerve stimulation
  • sham transcutaneous auricular vagus nerve stimulation
📍

Where

1 site
Max Planck Institute of Psychiatry
Munich, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy