Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study

Abstract

Invasive vagus nerve stimulation has been demonstrated to be an effective treatment in major depressive episodes. Recently, a novel non-invasive method of stimulating the vagus nerve on the outer canal of the ear has been proposed. In healthy subjects, a prominent fMRI BOLD signal deactivation in the limbic system was found. The present pilot study investigates the effects of this novel technique of auricular transcutaneous electric nerve stimulation in depressed patients for the first time. A total of 37 patients suffering from major depression were included in two randomized sham controlled add-on studies. Patients were stimulated five times a week on a daily basis for the duration of 2 weeks. On days 0 and 14, the Hamilton Depression Rating Scale (HAMD) and the Beck Depression Inventory (BDI) were assessed. In contrast to sham-treated patients, electrically stimulated persons showed a significantly better outcome in the BDI. Mean decrease in the active treatment group was 12.6 (SD 6.0) points compared to 4.4 (SD 9.9) points in the sham group. HAMD score did not change significantly in the two groups. An antidepressant effect of a new transcutaneous auricular nerve stimulation technique has been shown for the first time in this controlled pilot study. Regarding the limitations of psychometric testing, the risk of unblinding for technical reasons, and the small sample size, further studies are necessary to confirm the present results and verify the practicability of tVNS in clinical fields.

Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study

“…Regarding safety, our pilot study showed that active VNS is generally well tolerated and associated neither with stressful symptoms nor with relevant adverse effects. Our reported tolerability is in line with previous reports using tVNS for epilepsy, major depression and tinnitus [22,31,50].…”

“…Functional MRI studies have demonstrated that transcutaneous VNS significantly decreases blood oxygenation levels in various cortical and subcortical areas, particularly limbic structures [11,29]. A recently published monocentric clinical trial indicated that transcutaneous VNS is effective for the treatment of major depression [22], but failed to improve chronic tinnitus in another monocentric pilot trial [31]. Based on the expertise gathered from the animal, physiological and clinical studies discussed here, our goal was to determine, for the first time, the feasibility and efficacy of transcutaneous VNS for the treatment of schizophrenia.…”

Vagus nerve stimulation mediates protection from kidney ischemia-reperfusion injury through α7nAChR+ splenocytes

“…They are usually mild to moderate and seldom require that the device be explanted (47). Recently, 2 types of noninvasive transcutaneous VNS (t-VNS) devices, safe and tolerable alternative treatments, were developed, and they are in clinical trials for epilepsy, depression, and migraine (48)(49)(50)(51). These noninvasive devices might be effective in disorders classically treated with VNS and could potentially be applied to inflammation-related disorders.…”

Effects of Acute Transcutaneous Vagal Stimulation on the EEG Power Maps, EEG Sources Distribution and Steadiness of Quiet and Sensory-conflicted Stance

“…There is a fast growing interest in the transcutaneous vagal nerve stimulation (t-VNS), first proposed by Ventureira, 1 which is a promising treatment of refractory epilepsy, pain, depression and other neuropsychiatric diseases [2][3][4][5] and special stimulating devices are constructed for its application. 6 This method represents a noninvasive, safer and cheaper alternative of the cervical vagal nerve stimulation, studies that started in 1938 with cat experiments of Bailey and Bremmer 7 and established the vagal nerve as an important route in the central nervous system, which can be used for brain neuromodulation by the nonspecific stimulation information carried by vagal afferents.…”