The Parasym Device​ Significantly Increases Parasympathetic Activity​

Parasym Clinical Trial, 2018

In this study, Parasym neuromodulation on the auricular branch of the vagus nerve at the tragus for 1 hour resulted in a significant improvement in the sympathovagal balance in patients with diastolic dysfunction and preserved LV ejection fraction. The key findings related to the frequency domain parameters are as follows:

 

(A) LF (Low Frequency) normalised units (n.u.): Increased significantly from 61.7 ± 4.5 to 68.0 ± 4.3 in the Sham group and from 58.6 ± 4.5 to 41.3 ± 4.4 in the Nurosym group after 1 hour of stimulation.

 

(B) HF (High Frequency) normalised units (n.u.): Decreased significantly from 37.3 ± 4.5 to 31.8 ± 4.3 in the Sham group and increased significantly from 38.2 ± 4.4 to 41.3 ± 4.4 in the Neurosym group after 1 hour of stimulation.

 

(C) LF/HF ratio: Increased significantly from 2.2 ± 0.4 to 3.1 ± 0.4 in the Sham group and decreased significantly from 2.1 ± 0.4 to 1.8 ± 0.4 in the Neurosym group after 1 hour of stimulation.

 

These alterations indicate a shift towards more favourable autonomic modulation, characterised by a reduction in sympathetic outflow and an increase in parasympathetic tone. The improvement in the LF/HF ratio underscores the potential efficacy of non-invasive neuromodulation in the therapeutic management of conditions such as HFpEF, as demonstrated in this cohort group. This approach tends to enhance autonomic function and optimise cardiac mechanics over the long term. 

Parasym Clinical Trial, 2022

 

This study included 20 healthy participants. Participants abstained from caffeine, exercise, smoke, and alcohol in the 5 hours preceding the experiment and were blinded to active or sham treatment.

 

Autonomic function measured by HRV components was significantly affected in the active group (n=10) receiving Parasym neuromodulation compared to the placebo group (n=10) receiving placebo neuromodulation. After 5 minutes of neuromodulation the following HRV components were positively altered in the active group receiving Parasym neuromodulation compared to the placebo group:

 

(A) HF (High-Frequency Power)

(B) RMSSD (Root Mean Square of Successive Differences)

(C) pRR50 (Percentage of Successive RR Intervals > 50 ms Difference)

(D) SDRR (Standard Deviation of RR Intervals)

 

Changes HF, RMSSD, pRR50, and SDRR compared to baseline persisted in the active group during the recovery phase, 5 minutes after the neuromodulation was interrupted. No adverse effects were observed by any of the participants.

 

 

Parasym Clinical Trial, 2022

This study included 20 healthy participants. Participants abstained from caffeine, exercise, smoke, and alcohol in the 5 hours preceding the experiment and were blinded to active or sham treatment.

 

Autonomic function measured by HRV components was significantly affected in the active group (n=10) receiving Parasym neuromodulation compared to the placebo group (n=10) receiving placebo neuromodulation. After 5 minutes of neuromodulation the following HRV components were positively altered in the active group receiving Parasym neuromodulation compared to the placebo group.

 

(A) HF (High-Frequency Power)

(B) RMSSD (Root Mean Square of Successive Differences)

(C) pRR50 (Percentage of Successive RR Intervals > 50 ms Difference)

(D) SDRR (Standard Deviation of RR Intervals)

 

Changes HF, RMSSD, pRR50, and SDRR compared to the baseline persisted in the active group during the recovery phase, 5 minutes after the neuromodulation was interrupted. No adverse effects were observed by any of the participants.

Parasym Clinical Trial, 2018

 

In this study, Parasym neuromodulation on the auricular branch of the vagus nerve at the tragus for 1 hour resulted in a significant improvement in the sympathovagal balance in patients with diastolic dysfunction and preserved LV ejection fraction. The key findings related to the frequency domain parameters are as follows:

 

(A) LF (Low Frequency) normalised units (n.u.): Increased significantly from 61.7 ± 4.5 to 68.0 ± 4.3 in the Sham group and from 58.6 ± 4.5 to 41.3 ± 4.4 in the Nurosym group after 1 hour of stimulation.

 

(B) HF (High Frequency) normalised units (n.u.): Decreased significantly from 37.3 ± 4.5 to 31.8 ± 4.3 in the Sham group and increased significantly from 38.2 ± 4.4 to 41.3 ± 4.4 in the Neurosym group after 1 hour of stimulation.

 

(C) LF/HF ratio: Increased significantly from 2.2 ± 0.4 to 3.1 ± 0.4 in the Sham group and decreased significantly from 2.1 ± 0.4 to 1.8 ± 0.4 in the Neurosym group after 1 hour of stimulation.

 

These alterations indicate a shift towards more favourable autonomic modulation, characterised by a reduction in sympathetic outflow and an increase in parasympathetic tone. The improvement in the LF/HF ratio underscores the potential efficacy of non-invasive neuromodulation in the therapeutic management of conditions such as HFpEF, as demonstrated in this cohort group. This approach tends to enhance autonomic function and optimise cardiac mechanics over the long term.