TY - JOUR

T1 - Transcutaneous Vagal Nerve Stimulation in Treatment-Resistant Depression

T2 - A Feasibility Study

AU - Evensen, Kristin

AU - Jørgensen, Martin Balslev

AU - Sabers, Anne

AU - Martiny, Klaus

PY - 2022

Y1 - 2022

N2 - Background: Major depression (MD) contributes significantly to the global burden of disease with up to one-third of patients being treatment resistant. Therefore, the development of new treatment options for treatment-resistant depression (TRD) is needed. Vagus nerve stimulation (VNS) has shown mood improvements in patients with TRD. However, due to high costs related to the implantation and the invasive nature of VNS, an application with transcutaneous VNS (t-VNS) has been developed stimulating a vagal nerve branch in the earlobe (Arnold's nerve). A few studies with t-VNS in MD has shown a possible antidepressant effect, but feasibility is poorly described and patients with TRD have not been investigated. Objectives: As the full antidepressant effect of t-VNS takes months we wanted to assess feasibility and side effects of daily treatments. Materials and Methods: Single-arm feasibility trial assessing compliance, usability, side effects, cognitive speed, and depression in a four-week period with a recommended t-VNS stimulation duration of four hours per day in patients with TRD. The primary outcome was compliance with 80% of the recommended daily treatment time. Results: Compliance threshold was reached for 80.0% of the 20 included participants. Usability was acceptable. Side effects were few, mild or moderate, mostly as local effects at the contact point in the ear. The device was difficult to use for some participants. A statistically significant reduction in depression severity and an increase in cognitive speed were seen with unchanged suicidal ideation and sleep. Conclusions: We would recommend larger long-term randomized studies of t-VNS to access any antidepressant effect in TRD. The design of the device might be improved for higher usability.

AB - Background: Major depression (MD) contributes significantly to the global burden of disease with up to one-third of patients being treatment resistant. Therefore, the development of new treatment options for treatment-resistant depression (TRD) is needed. Vagus nerve stimulation (VNS) has shown mood improvements in patients with TRD. However, due to high costs related to the implantation and the invasive nature of VNS, an application with transcutaneous VNS (t-VNS) has been developed stimulating a vagal nerve branch in the earlobe (Arnold's nerve). A few studies with t-VNS in MD has shown a possible antidepressant effect, but feasibility is poorly described and patients with TRD have not been investigated. Objectives: As the full antidepressant effect of t-VNS takes months we wanted to assess feasibility and side effects of daily treatments. Materials and Methods: Single-arm feasibility trial assessing compliance, usability, side effects, cognitive speed, and depression in a four-week period with a recommended t-VNS stimulation duration of four hours per day in patients with TRD. The primary outcome was compliance with 80% of the recommended daily treatment time. Results: Compliance threshold was reached for 80.0% of the 20 included participants. Usability was acceptable. Side effects were few, mild or moderate, mostly as local effects at the contact point in the ear. The device was difficult to use for some participants. A statistically significant reduction in depression severity and an increase in cognitive speed were seen with unchanged suicidal ideation and sleep. Conclusions: We would recommend larger long-term randomized studies of t-VNS to access any antidepressant effect in TRD. The design of the device might be improved for higher usability.

KW - Psychiatric somatic therapies

KW - treatment-resistant depression

KW - vagus nerve stimulation

U2 - 10.1111/ner.13366

DO - 10.1111/ner.13366

M3 - Journal article

C2 - 35396074

AN - SCOPUS:85100345657

VL - 25

SP - 443

EP - 449

JO - Neuromodulation: Technology at the Neural Interface

JF - Neuromodulation: Technology at the Neural Interface

SN - 1094-7159

IS - 3

ER -