February 2022: In time for World Heart Month, Parasym™ in partnership with the University of Oklahoma announce groundbreaking research into neuromodulation treatment for heart failure.
The randomised-controlled trial, led by principal investigator Dr. Stavros Stavrakis at the University of Oklahoma’s Health Sciences Centre used the Parasym™ neuromodulation device to significantly improve cardiac mechanics and quality of life, and reductions in inflammatory markers in a patient population that historically has very few treatment options available. The positive results pave the way for a new era of heart failure treatment.
Currently, heart disease is the leading cause of death globally, taking an estimated 17.9 million lives each year. One person dies every 36 seconds in the United States from heart disease. In the UK heart and circulatory diseases cause a quarter of all deaths which is an average of an astounding 460 deaths per day. As the fastest growing form of heart disease, heart failure is accounting for a significant proportion of all cases.
Today’s landscape for heart failure is complex as there is no cure for the debilitating condition. Until Parasym™ launched the first of its kind neuromodulation device, there have been no clinically validated, non-invasive, non-pharmacological options for people who suffer from heart failure and its plethora of life-altering symptoms. As many as one-quarter of patients report intermediate to severe depression in association with heart disease because it drastically impacts their quality of life. Up until now, depression as a side effect is something that the medical field has failed to focus on when considering how to treat heart failure because naturally, their priority has been the prevention of death and hospitalisation. Additionally, there are many risks and possible side effects of taking medication to treat the disease, which is mostly triggered by the right medicine ending up in the wrong places. Whereas, neuromodulation and electroceuticals have the capacity to provide a highly targeted treatment.
Current treatment advises lifestyle changes and medication, which is not without side effects. Electroceuticals are set to revolutionise the treatment paradigm in heart failure, especially neuromodulation with its capacity to provide highly targeted treatment without drug interaction or side effects.
The results from the clinical trial using Parasym’s neuromodulation device demonstrate that Parasym – the only non-invasive, low risk and minimal side effect option – has significantly improved the quality of life for patients suffering from heart failure. The device works by stimulating the vagus nerve and sending signals to the brain, which favourably alters the nervous system and reduces inflammation of the heart.
The clinical results of using neuromodulation to help significantly ease the symptoms of heart failure showed that the patients who took part in the placebo-controlled study experienced measurable improvements from as little as three months of using the device for less than an hour per day. The study revealed significant improvements in levels of proinflammatory cytokines Interleukin-8 and Tumour Necrosis Factor alpha, indicating that the treatment had a significant anti-inflammatory effect, as well as in global longitudinal strain, a core indicator of cardiac mechanics.
Importantly, patients also reported improved quality of life and in their day to day activities, which is something that surgery and medication struggle to deliver. Furthermore, as the neuromodulation device is non-invasive, patients are able to use it in addition to medication should they want to. This approach fills a gap by addressing the patient’s overall quality of life, as well as improving their mental health which is impacted by living with the condition.
Sophie Dundovic, Co-Founder at Parasym™ commented: “The international impact of heart failure on our population is staggering with millions of individuals suffering on a daily basis with symptoms impacting their quality of life. Parasym™️ is committed to supporting groundbreaking cardiac research and we are working to bring non-invasive electroceutical treatments to patients suffering from heart failure.
“The results published in the Journal of the American Heart Association highlight the brilliant work done by researchers at the University of Oklahoma and show the incredible potential that Parasym’s neuromodulatory technology can have in a condition where there is an urgent unmet clinical need for new treatment options. We are incredibly proud of the trial results and hope to continue to demonstrate the positive impact of neuromodulation in healthcare.”
Dr Stavros Stavrakis MD, PhD, Associate Professor at University of Oklahoma College of Medicine commented: “We conducted a sham-controlled, double-blind, randomized clinical trial to examine the effect of chronic low-level transcutaneous vagus nerve stimulation on cardiac function, exercise capacity, and inflammation in a subgroup of patients with heart failure with preserved ejection fraction with a predominantly inflammatory-metabolic phenotype. In this patient population, neuromodulation with low-level transcutaneous vagus nerve stimulation over three months resulted in a significant improvement in global longitudinal strain, inflammatory cytokines, and quality of life. Our results support the emerging paradigm of noninvasive neuromodulation to treat selected patients with heart failure with preserved ejection fraction and provide the basis for further randomized trials.”
Parasym™ is the only company to have developed a device that utilises advances in electroceutical technology to provide ground-breaking non-invasive treatment for numerous health and wellness conditions ranging from mental to physical health including heart failure, without the need for medication. For further information about Parasym™ visit parasym.co.
