Studies how non-invasive ear nerve stimulation may help depression
Tests ear-based vagus nerve stimulation against a sham device in adults with depression.
Plain-language title generated from the registry record
Registry title: Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression
Key facts
- Where
- Munich, 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 65 years old?
Source: NCT07022171, who can take part
Where in Germany
- Max-Planck-Institute of PsychiatryMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Max-Planck-Institute of Psychiatry
- Trial code
- NCT07022171
- Record updated
- 15 June 2025
- Original description
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 going to receive either tVNS or sham tVNS for a period of 6 weeks. The primary objective of the study is to identify biological, psychological, socio-economic, and clinical biomarkers associated with treatment progression and response to treatment in patients with depression undergoing tVNS. To achieve this, an exploratory design with an assessment of many different parameters including psychophysiology, imaging, blood-based multi-omics, microbiome, psychometrics and neuropsychology will be used.Read full original descriptionShow less
Physiological and Molecular Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression
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 going to receive either tVNS or sham tVNS for a period of 6 weeks. The primary objective of the study is to identify biological, psychological, socio-economic, and clinical biomarkers associated with treatment progression and response to treatment in patients with depression undergoing tVNS. To achieve this, an exploratory design with an assessment of many different parameters including psychophysiology, imaging, blood-based multi-omics, microbiome, psychometrics and neuropsychology will be used.
Inclusion: age 18-65 years, legally competent and able to provide informed consent; diagnosis of a depressive episode (MDD or bipolar disorder) according to DSM 4/DSM 5 or ICD-10/ICD-11; signed informed consent documents for the AddVNS study; signed informed consent and participation in the biobanking project of MPIP; use of a safe contraceptive method.
Exclusion: acute substance abuse (e.g., alcohol, prescription or illicit drugs); current treatment with an established neurostimulation method (e.g., ECT, rTMS, VNS); pervasive developmental disorders and/or intellectual disability; severe neurological disease; severe general illness (e.g., relevant anemia requiring transfusion, high-grade cardiac arrythmia, severe cardiomyopathy); active implants (e.g., cochlear implant, cardiac pacemaker, implantable cardioverter-defibrillator); age < 18 years or age > 65 years; pregnancy or planning to get pregnant during the study period, breastfeeding; legal supervision; technically or anatomically not possible tVNS (e.g., microtia or anotia, vagotomy); metallic foreign bodies, implanted intracranial devices or cerebral shunts.