SPECIAL THANKS
This report provides a concise overview of the results of the study and is intended both to present the results and to facilitate ongoing feedback on the programs. We are in the process of preparing everything for publication in a peer-reviewed journal and will continue to keep our customers informed. It is important to note that this study represents one of the largest PEMF (Pulsed Electromagnetic Field) studies focused on the vagus nerve and is the first of its kind. This innovative research underscores our ongoing efforts to explore and advance the use of PEMF therapy in neurostimulation, with a focus on its potential benefits for health and wellness.
Should you have any questions, please feel free to reach out to Marko Kadunc at foryou@omnipemf.com.
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Marko Kadunc, CEO at MDCN TECH
Introduction
General Information Regarding The Study
Date of Study Research Duration: March 25, 2023 – January 10, 2024
Device: The PEMF stimulation device used in the study was a NeoRhythm U-band
Purpose: Assessment of User Experiences with NeoRhythm’s Three Frequency Settings for Pulsed Electromagnetic Field (PEMF) Stimulation of the Vagus Nerve at the Neck, Conducted Under Blinded Conditions Including Placebo Control.
PEMF Stimulation Of Vagus Nerve
In the domain of neurological therapies, the stimulation of the vagus nerve (hence VNS) has emerged as a frontier of significant interest and potential. This nerve, known for its extensive reach and influence over various bodily functions, has been the target of numerous therapeutic techniques, ranging from invasive surgical implants to non-invasive auricular (ear) stimulation. Each method, with its unique approach, aims to harness the vagus nerve’s capacity for modulating numerous physiological processes, including heart rate, gut motility, and mood regulation.
Among these varied techniques, one method that has garnered attention in various treatment fields yet remains shrouded in uncertainty regarding VNS is PEMF stimulation applied through the neck. Unlike its counterparts concerning electrical stimulation, which has been subject to rigorous clinical trials and scientific scrutiny, PEMF therapy in this context appears to be in its beginner’s phase, with a conspicuous absence of robust, peer-reviewed studies that would validate its claims.
This critical gap in scientific evidence raises important questions about the reliability of the neck-applied PEMF VNS as a means of vagus nerve modulation. As we explore the diverse landscape of VNS techniques, it becomes imperative to differentiate between well-researched, scientifically validated methods and those still waiting for them.
It is therefore clear why this present study represents such a breakthrough in the field of both PEMF stimulation per se (as it was performed as a blinded study on an initial sample of 485 volunteers) and PEMF stimulation of the vagus nerve. Of all the methods reviewed in the published scientific literature, only PEMF stimulation can be said to be truly non-invasive, especially at the applied magnetic flux intensity of 2.5 mT.
This study was based on previous bibliometric studies of the use of minimally invasive VNS methods. On this basis, we decided to employ three different frequencies: 32 Hz, 16 Hz, and 6 Hz, and a placebo effect (no stimulation, where volunteers thought they were stimulated).
The study was carried out through questionnaires representing three sets: an introductory questionnaire clarifying a little more about the volunteer, ongoing questionnaires as the stimulation took place, and a final one after one week elapsed from the end of the stimulation so that we could also identify more long-term post-PEMF VNS effects.
Results And Discussion
Input Characteristics Of The Participants
Initially, the participants were divided into four groups. However, a group with a minimal PEMF frequency of 6 Hz was added to the control group as no differences were found between them. As previously mentioned, VNS runs at higher frequencies. A total of 446 individuals who met the inclusion criteria, completed the initial questionnaire and at least one additional questionnaire from the subsequent waves. Thus, we analyzed 199 respondents from the control (0 and 6 Hz) group, 123 respondents from the 16 Hz group, and 124 respondents from the 32 Hz group.
Sociodemographic Characteristics Of Participants
In this section, we provide a summary of the participants’ employment status, age distribution, perceptions of job-related stress, prevalent medical conditions, and tobacco use. Our analysis aims to uncover the complex relationships between these variables and their impact on individual health and well-being.
Figure 4: The Employment Status
Figure 4 shows that almost half of the participants are employed, and a quarter are self-employed. Retirees make up just under one-fifth of the participants, while other employment groups are represented in less than 5%.
Figure 5: Age category
Figure 5 illustrates the shares of participants according to age categories. Almost half are aged between 41 and 60 years, and around a quarter are younger or older.
Figure 7: Job-related stress self-evaluation.
Participants rated the stress level of their work on a five-point scale (Figure 7). One-fifth of them feel that they have slight or no stress at work, the majority (44%) assess their work as moderately stressful, while more than a third experience their work as very or extremely stressful.
Figure 8: Medical conditions.
Roughly half of the respondents have any pre-existing medical conditions (Figure 8), while two-thirds are currently taking any medications or supplements.
Figure 9: Tobacco and caffeine intake.
(Figure 9). Almost half are those reporting low caffeine intake and a third moderate. One in ten respondents use tobacco products and the vast majority consume caffeine products
Study Results
The questionnaire utilized the VAS scale from 0 to 100 to address the effects of the program. Respondents estimated various aspects of their health and psychological state in seven measurement waves over five weeks. The main inquiry was whether their condition improved over time and if there were any differences between groups. The figures below illustrate the trend of mean VAS estimates over time, separately for the control and two experimental groups. The estimates have been normalized based on each individual’s initial state before the start of the experiment. The estimates represented by positive values are higher than those of the initial state, while negative values indicate lower estimates.
The parameter ‘General well-being’ was calculated as the mean value of the VAS estimates for quality of sleep, general state of health, overall energy level, and overall level of contentment (refer to Figure 10).
Figure 10: Relative improvement in well-being.
The left side of Figure 10 shows how VAS estimates for the general well-being changed throughout the measurements. The most significant average improvement relative to the initial VAS estimates was observed after just three days of the start of stimulation in the 16 Hz group, which continued to increase throughout the measurements, surpassing the other two groups. The control group exhibited the least improvement, with general well-being improving on average by 0.8 points of the VAS scale with each measurement, reaching an increase of around 5 points after a month. This improvement can be attributed to daily relaxation. In the 32-Hz group, the average well-being improved by 1.1 points in each measurement, resulting in a total improvement of 7 points after a month of stimulation. In the 16 Hz group, the average improvement with each measurement was 1.7 points, reaching an overall improvement of approximately 9 points after a month.
Particularly illustrative are the results for the groups on the right side of Figure 10, based on the individuals who reported an initial low level of well-being (mean VAS estimate <=50). All groups achieved better results after 30 days compared to the groups in the overall sample. The 16-Hz group experienced a significant improvement in the level of well-being, with an average increase of 3 points after just three days and an impressive 15 points after 30 days. In summary, it can be concluded that to improve overall well-being, the most effective is the VNS at the frequency of 16 Hz, especially for those individuals who experience very low levels of well-being. Figure 11: Relative improvement of sleep. As seen in Figure 11, we also focused on an important aspect of overall well-being, namely, sleep quality. The figure above shows the results for the total sample of the respondents. In the 16-Hz group, which proved to be the most effective once again, sleep quality increased by an average of 2.1 points with each measurement up to 15 points at the end of the stimulation period. The 32-Hz group improved sleep quality by an average of 1.3 points with each measurement, and after 30 days, the improvement reached 8 points. In the control group, there was an average improvement of one point with each measurement, and after a month, the improvement was 5 points. Here, again, we can say that 16 Hz simulation is the most effective. Based on the results of ANOVA analysis, statistically significant differences between the groups are observed on the 6th and 11th days. The Tukey post hoc test revealed the differences between the control and 16 Hz groups (pday6=0.015; pday11=0.004).
Figure 12: Relative decrease of stress.
After a month in all groups, the stress level dropped, indicating the importance of daily relaxation (Figure 12) even without stimulation. On average, the control (placebo effect) group reduced it by 15 points or around 2.1 points per measurement. The group that received VNS at a frequency of 16 Hz exhibited a slight improvement, with an average reduction of 2.4 points per successive measurement. This resulted in a reduction of over 16 points after a month. On the other hand, the 32-Hz group demonstrated a significantly better outcome, reducing stress by an average of 3.1 points per measurement, achieving an average reduction of 23 points after 30 days. In reducing stress, therefore, PEMF VNS via neck worked the most effectively at the frequency of 32 Hz. The most evident difference in stress reduction compared to the initial state was observed on the 6th day. Analysis of variance confirmed a statistically significant higher reduction in stress in the 32 Hz group compared to the control group and the 16 Hz group (pcontrol vs. 32 Hz= 0.017; p16 Hz vs. 32 Hz= 0.019).
Figure 13: Relative reduction of anxiety.
Similarly to the stress reduction, we can also observe a decrease in anxiety (Figure 13). Relaxation has proven to be an important factor in reducing anxiety, particularly when combined with VNS. After a month, stimulation at either 16 Hz or 32 Hz reduced anxiety by an average of 15 points, while placebo-induced relaxation alone reduced it by only 11 points. Since both, stress and anxiety have a similar effect on relaxation plus VNS, we combined the data for both observed parameters and obtained the following measurement effect curve (see Figure 14).
The very noteworthy point here is that we obtain a statistically significant difference for each day of measurement, in particular between the 32 Hz group and the Control (placebo). In Figure 15, the same development through time is presented, only this time in percentage from the beginning self-assessment (=100%).
Figure 14: Reduction of stress and anxiety presented in points of VAS scores.
Figure 15: Reduction of stress and anxiety presented in percentage from the beginning (=100%). In addition to trend analyses, we also performed analyses regarding the percentage of participants who reported improvement in a desired direction at stated checking points. The results are presented in Figures 16 – 18.
Figure 16: In every assessment, the proportion of participants who experienced over a 5% enhancement in their well-being was the highest among the 16 Hz group.
Figure 17: Starting from Day 6, the highest percentage of participants noting a decrease in stress levels was in the 32 Hz group. The highest differences are observed for Days 6 and 11.
Figure 18: Beginning on Day 6, the largest proportion of participants reporting improvements in sleep was observed in the 16 Hz group. A high difference may also be seen towards the end of stimulation (Days 23 and 30). The effects after the end of the VNS (7-day post-effect survey) show that in most cases, in all groups (VNS and placebo), the effects start to shrink. For the combination of stress and anxiety parameters, a continuation of the difference, i.e., no decrease, can be observed for both VNS and placebo groups (Figures 14, 15). Another exception is the general well-being parameter (related to Figure 10), where VNS 32-Hz and placebo differences started to diminish, but the 16-Hz group nevertheless maintained the level achieved by Day 30. In every case, the relative differences between placebo effect and VNS treatment endured, even if they gradually started to diminish.
Conclusions
When evaluating the effectiveness of transcutaneous electrical VNS, the placement of the device on the neck is crucial in stimulating the vagus nerve and enhancing the potential therapeutic benefits of the stimulation.
The two frequencies that most closely match the commonly used transcutaneous electrical VNS (32 Hz and 16 Hz) showed different levels of effectiveness in improving general well-being or reducing stress.
- 16 Hz stimulation achieved the highest score in enhancing general well-being, 16 Hz stimulation also significantly improves sleep. The effectiveness is even higher if there is an initial low level of well-being.
- With stress reduction, 32 Hz stimulation is the most effective, while to combat anxiety, both frequencies proved to be equally effective
- In both cases, the effect can also be seen one week after the cessation of stimulation, which speaks in favor of prolonged (long-term) influence.
- Overall, the best effects are seen from Day 6 to Day 11.
- The effects last even seven days after cessation (Day 23) of stimulation (Day 30); however, they begin to shrink.
- In terms of percentage, the stimulation may bring effects similar to using medicals, i.e., for 25% as may be seen in Figure 15.
The stimulation was blinded with respect to frequency or placebo effect, so the observed effects represent the objective influence of the applied neck PEMF stimulation (16 Hz and 32 Hz) over placebo, which also exhibited effects. It looks like the effectiveness of 6 Hz stimulation wasn’t really shown, since the results were mixed with those of a placebo (control, no stimulation).
Guidelines
- Use once or twice per day
- It is not entrainment; the PEMF VNS via NeoRhythm beck application works on the vagus nerve, which is differently responsive to stimulation than the brain.
- For stress or anxiety reduction, use a 32 Hz stimulation frequency.
- For general well-being or sleep disturbances, use a 16 Hz stimulation frequency.
- If after two weeks of usage, you do not feel the effects anymore, do a pause for 3-4 days and then continue with your habitual sessions.
Bibliography
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