RECRUITINGINTERVENTIONAL

Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression

Physiological and Molecular Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. age 18-65 years, legally competent and able to provide willing to sign a consent form; 2. diagnosis of a depressive episode (MDD or bipolar disorder) according to DSM 4/DSM 5 or ICD-10/ICD-11; 3. signed willing to sign a consent form documents for the AddVNS study; 4. signed willing to sign a consent form and participation in the biobanking project of MPIP; 5. use of a safe contraceptive method Who Should NOT Join This Trial: 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DEVICE

transcutaneous auricular vagus nerve stimulation

Half of the patients are randomized to the arm receiving transcutaneous auricular vagus nerve stimulation for a period of six weeks. Transcutaneous auricular vagus nerve stimulation will be carried out as an adjuvant, i.e. in addition to the regular treatment of the participants. The intervention will take place three times a day from Monday to Friday. Each of the three daily sessions is going to last 30-60 minutes, depending on patient tolerance.

DEVICE

sham transcutaneous auricular vagus nerve stimulation

Half of the patients are randomized to the arm receiving sham transcutaneous auricular vagus nerve stimulation for a period of six weeks. Sham transcutaneous auricular vagus nerve stimulation will be carried out as an adjuvant, i.e. in addition to the regular treatment of the participants. The intervention will take place three times a day from Monday to Friday. Each of the three daily sessions is going to last 30-60 minutes. The procedures for sham tVNS will be identical to tVNS, with the only exception that the sham tVNS will be performed with no current output

Locations (1)

Max Planck Institute of Psychiatry

Munich, Germany