aVNT in POTS - Pilot

Summary

Autonomic nervous system imbalance causes postural tachycardia and related cardiac symptoms in Postural Orthostatic Tachycardia Syndrome (POTS). The impact of POTS is more far-reaching than postural tachycardia. Several systemic, autonomic symptoms along with neuro-cognitive dysfunction leading to poor quality of life contribute to significant disability in POTS. A combination of abnormal autonomic tone, abnormal cerebral blood flow regulation, and systemic inflammation may contribute to POTS symptoms.

Auricular Vagal Neuromodulation Therapy (aVNT) has the potential for multisystem holistic benefit for patients with POTS: Autonomic neuromodulation by aVNT might address multiple aspects of POTS pathophysiology and improve POTS symptoms. It can reduce postural tachycardia by increasing the parasympathetic (PNS) and decreasing sympathetic (SNS) tone. In patients undergoing vagus nerve stimulation for various indications, an increase in PNS tone has been associated with improved middle cerebral artery velocity (MCAv) at rest and during cognitive stress. aVNT has been associated with improved cerebral blood flow and reduced infarct size in an experimental model of ischemic stroke, suggesting similar improvements in cerebral autoregulation in POTS. Vagus nerve stimulation has also been linked to improved cognitive function. The anti-inflammatory effect and improved endothelial function might improve cerebral blood flow regulation and cognitive function. The anti-inflammatory effects of aVNT may improve postural hemodynamics, reduce postural tachycardia, relieve other POTS symptoms, and improve quality of life (QoL). POTS is a complex multisystem disorder with debilitating symptoms that currently lack effective treatments. aVNT has the potential to recalibrate autonomic tone dysregulation, enhance MCAv, improve cognitive function, reduce inflammation, and ultimately improve symptoms and quality of life in POTS patients.

Conditions

• Postural Orthostatic Tachycardia Syndrome (POTS)

Interventions

DEVICE

active aVNT vs. Sham

Patients in both groups will receive daily stimulation with the Parasym device, temporarily connected to the tragus of the right ear (Fig 2).54 The stimulation parameters will be frequency of 20 Hz, pulse width of 200 µs, and the stimulation amplitude will be titrated to 1 mA below the discomfort threshold, consistent with parameters used in published clinical studies.54-56 With this stimulation at just below the discomfort threshold, people will often feel the stimulation for less than 60 seconds before they lose awareness of the ongoing stimulation. The stimulation will continue for 1 hour daily for 3 months, and we will track its use with a patient diary. Participants can continue their regular activities while wearing the aVNT device, as long as it is not soaked in water. Parasym will obtain Health Canada approval for use of their device in the study.

Sponsors & Collaborators

• University of Calgary

  lead OTHER

Principal Investigators

• Satish Raj, MD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2031-12-31

Completion

2031-12-31