Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression

Sponsor
Max-Planck-Institute of Psychiatry
Study ID
NCT07022171
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • transcutaneous auricular vagus nerve stimulation — DEVICE
    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.
  • sham transcutaneous auricular vagus nerve stimulation — DEVICE
    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

Study Details

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.

Key Dates

First listed
Jun 15, 2025
Start date
Mar 18, 2025
Status verified
Apr 2025
Primary completion
Mar 17, 2030
Completion
Mar 17, 2030

Study Design

Enrollment
86 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: tVNS-arm (transcutaneous auricular vagus nerve stimulation)
    Half of the patients are randomized to the arm receiving transcutaneous auricular vagus nerve stimulation in addition to their regular treatment for a period of six weeks
  • Sham Comparator: sham tVNS-arm (sham transcutaneous auricular vagus nerve stimulation)
    Half of the patients are randomized to the arm receiving sham transcutaneous auricular vagus nerve stimulation in addition to their regular treatment for a period of six weeks. 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

Primary Outcome Measure

Change from baseline in pupillometry [ Time Frame: Baseline, week 3, week 6 ]

Central Contacts

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