Our Solution: Non-Invasive Vagus Nerve Stimulation for Depression and Anxiety
Protocol abstract:
Depression and anxiety are common mental health disorders that affect millions of people worldwide. Despite the availability of various treatments, a significant proportion of patients continue to suffer from these conditions. Non-invasive vagus nerve stimulation (taVNS) is a promising new treatment for these disorders, which has shown positive results in early clinical trials.
The objective of this study is to reveal the pattern of heart rate variability (HRV) parameters changes during taVNS and sham treatment, and understand the basis for the therapeutic effect of taVNS. The study will assess baseline HRV in a cohort of major depressive disorder (MDD) patients and correlate baseline HRV and symptomatology/severity of MDD. The cardiac vagal tone will be modulated through taVNS treatment.
The second objective is to explore HRV biomarkers that might predict the success of taVNS longitudinal treatment even before the first treatment and identify patients that could benefit the most from taVNS. The study will assess the potential association between HRV ranges of changes from baseline and clinical outcomes during and after taVNS treatment.
The hypothesis of the study is that MDD patients with lower vagal activity indexed by vagally-mediated heart rate variability (vmHRV) will benefit more from taVNS treatment than MDD patients with higher baseline vagal activity. The results of this study will provide crucial information about the association between HRV increase during taVNS stimulation and the clinical outcome, and could pave the way for more effective treatments for depression and anxiety.