A pilot study on high amplitude low frequency–music impulse stimulation as an add‐on treatment for depression

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Abstract
Objective: High Amplitude Low Frequency–Music Impulse Stimulation (HALF‐MIS) is a form of Vagus Nerve Stimulation (VNS). The aim of the study was to determine the feasibility, efficacy, and potential side effects of HALF‐MIS, used as an add‐on treatment for depression.Methods: This is an open randomized controlled pilot study. Patients with depressive disorder were randomly allocated to either a HALF‐MIS group with eight add‐on HALF‐MIS sessions (over a period of 3–4 weeks) or a control group which received treatment as usual. Seated in a specially designed chair() embedded with a transducer, their central nervous system was stimulated through the abdomen, () using music and vibration. Hamilton rating was performed. Side effects were registered.Results: Eighteen patients were randomized to the add‐on treatment and 20 patients to the control group. Both groups show in Hamilton Depression Rating Scale (HDRS)‐17 and in HDRS‐6, although the HALF‐MIS group had a greater decline of symptoms. This was a significant difference in intergroup analysis (p = .011, CI 95% for the HALF‐MIS group 3.0588–8.5327 and CI 95% for the control group 0.2384–3.0). The (HDRS)‐6 difference was also significant (p = .020, CI 95% for the HALF‐MIS group 1.5911–5.0487 and for the control group −0.297 to 1.7058). No side effects were observed.Conclusions: High Amplitude Low Frequency–Music Impulse Stimulation treatment seems to give beneficial effect as an add‐on treatment for depression. HALF‐MIS appears to be a safe and effective add‐on treatment for depression.

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