Auricular Vagal Neuromodulation Therapy to Suppress Atrial Fibrillation Autonomic

Abstract

Patients with paroxysmal atrial fibrillation (AF) received Nurosym’s Auricular Vagal Neuromodulation Therapy and placebo stimulation for 6 months. Results showed that daily stimulation of the vagus nerve significantly reduced AF burden by 85% and decreased inflammatory markers, specifically TNF-alpha levels by 23%, compared to the placebo group. This indicates that Nurosym may be an effective non-invasive treatment for AF, potentially stabilising heart function and reducing the need for medications. The findings suggest that low-level vagus nerve stimulation restores autonomic balance and offers protective antiarrhythmic effects.

Background and aims

The study aimed to investigate the effects of Nurosym on patients with paroxysmal atrial fibrillation (AF). Research shows that the effect on the autonomic nervous system is becoming a key element in the treatment of atrial fibrillation (AF). By modulating the activity of the vagus nerve, it's possible to influence the overall balance of the autonomic system, potentially stabilising the irregularities associated with AF. Stimulation of the vagus nerve may prove to be a non-invasive treatment method that replaces the constant need for medications.

Methods

The study employed a prospective, double-blind, placebo-controlled, randomised clinical trial design. Patients with documented paroxysmal AF were eligible for inclusion. Participants were randomly assigned in a 1:1 ratio to either the active Nurosym neuromodulation group or a placebo control group. The active group received one hour of daily stimulation on the tragus for six months, where the auricular branch of the vagus nerve is located. In contrast, the placebo group received the same duration of stimulation on the earlobe, which lacks vagal innervation, ensuring an effective comparison. Patients underwent continuous ECG monitoring for two weeks at baseline, three months, and six months to assess the AF burden, defined as the percentage of time spent in AF during the monitoring period. Additionally, a 5-minute ECG was performed at these time points to assess heart rate variability (HRV). Blood samples were also collected for cytokine analysis. Statistical analyses involved comparing mean outcomes.

Results

The study found that Nurosym not only significantly shortened the duration of AF episodes, but also reduced inflammatory markers in patients with drug-resistant paroxysmal AF. This suggests that Nurosym may be an effective therapeutic option for treating AF symptoms in patients who do not respond adequately to standard pharmacological therapies.

At the six-month follow-up, the active group saw a significant reduction in AF burden—an 85% decrease compared to the placebo group (p = 0.011). Additionally, serum TNF-alpha levels were significantly lower in the active group by 23% (p = 0.0093), indicating an anti-inflammatory effect of the stimulation.

Conclusion

Atrial fibrillation (AF) burden is a significant clinical endpoint with implications for broader cardiovascular and neurological outcomes. This study demonstrated that Nurosym, an innovative method of neuromodulating the auricular branch of the vagus nerve, significantly reduces AF burden over a six-month period in patients with paroxysmal AF. Interestingly, while vagus nerve stimulation has historically been used to induce AF in experimental settings, when applied at low levels, such as with Nurosym, it appears to offer protective and antiarrhythmic effects without significantly slowing the heart rate. The results further indicate that Nurosym effectively restores sympathovagal balance to a more physiological range, suggesting that it not only reduces the frequency and severity of AF episodes but also improves overall heart function and stability.