ParasymTM neuromodulation technology was revealed to significantly decrease postural tachycardia at a late breaking clinical trial presentation at Heart Rhythm Society 2023. The groundbreaking study shows the potential for a safe and effective treatment to support the estimated 16 million people living with the condition.
Is Parasym the answer to POTS?
Postural Orthostatic Tachycardia Syndrome (POTS) is a condition characterized by an abnormal increase in heart rate upon standing. The condition has debilitating symptoms including anxiety, insomnia, chronic fatigue, weakness, headaches and brain fog. An estimated 80-85% of sufferers of POTS are women and many are starting their working lives. Studies show that a quarter (25%) of them have such severe side effects that they are unable to work. However, currently, there are no recommended treatments.
Reports also suggest that 14% of long covid sufferers may develop POTS. It is the most prevalent form of dysautonomia in young people and is estimated to affect up to 16 million people globally, as well as associated with significant morbidity and poor quality of life.
The presented randomized-controlled trial, led by principal investigator Dr Stavros Stavrakis at the University of Oklahoma’s Health Sciences Centre, used the Parasym™ neuromodulation system to test the clinical efficacy of targeted neuromodulation in postural orthostatic tachycardia syndrome (POTS).
Parasym treatment has been shown in RCTs to be anti-arrhythmic and anti-inflammatory, key mechanisms which have application to POTS.
Clinical trial details
We conducted a sham-controlled, double-blind, randomized clinical trial to examine the effect of Parasym treatment on POTS over a 2-month period relative to placebo treatment. Participants received Parasym treatment via a self administered wearable device for 1 hour daily over a 2-month period. Heart rate was monitored daily using wearable devices. Postural tachycardia was assessed during the baseline and 2-month visit. Heart rate variability (HRV) based on 5 min ECG, serum cytokines and anti-autonomic autoantibodies were measured at the respective time points. Outcomes were compared between the 2 arms using a mixed regression model, after adjusting for baseline values.
Results
Mean age was 34±11 years (100% female; 81% Caucasian). Baseline characteristics were balanced between the 2 arms. Treatment adherence was 83% in the active and 86% in the sham arm (p>0.05). No medication changes occured during follow up.
Postural tachycardia (in the absence of blood pressure drop) was significantly less in the active arm compared to the sham arm at 2 months (postural increase in heart rate 18±10bpm vs. 32±14bpm, respectively, p=0.016).
Anti-autonomic autoantibodies (α1-AR and β1-AR) were lower in the active arm compared to sham at 2 months (p<0.05). No device-related side effects were observed. Continuous heart rate monitoring HRV and cytokine analysis are currently underway.
Application
These results support the emerging paradigm of Parasym’s noninvasive neuromodulation to treat POTS, a condition with no FDA approved treatments. Mechanistically, this effect appears to be related to reduction of anti-autonomic autoantibodies.