Pulsetto: The Future of Non-Invasive Vagus Nerve Stimulation for Stress, Sleep, and Pain Relief

By Emily israt
3 min read
Pulsetto: The Future of Non-Invasive Vagus Nerve Stimulation for Stress, Sleep, and Pain Relief

Pulsetto is a non-invasive, bilateral vagus nerve stimulation (BnVNS) device designed to help reduce stress, anxiety, improve sleep quality, alleviate burnout, and support immunity. Unlike many competitors that focus on one side of the neck (such as gammaCore), Pulsetto delivers simultaneous, mild electrical pulsations to both sides of the cervical vagus nerve. This bilateral approach aims to achieve more comprehensive neuromodulatory effects and potentially greater therapeutic benefits.

The vagus nerve is the longest cranial nerve in the body, extending from the brainstem through the neck into the thorax and abdomen. It acts as a vital communication pathway between the brain and various internal organs, influencing functions such as heart rate, digestion, and stress response. Neuromodulation through vagus nerve stimulation (VNS) works by sending gentle electrical pulses along this nerve, helping to balance the autonomic nervous system and reduce symptoms related to stress, chronic pain, and migraines.

Currently, Pulsetto is marketed as a wellness device. However, we are actively working toward obtaining Medical Device Regulation (MDR) status in the EU and FDA approval in the United States by 2025. These steps will allow us to expand Pulsetto’s usage for the following indications:

  • Psychological stress & anxiety.

  • General sleep disorders.

  • Episodic and chronic migraine.

  • Chronic pain.

How Pulsetto Works

Pulsetto’s wearable design delivers mild pulses for 4–20 minutes per session, depending on the user’s selected program. The intensity level can be easily adjusted, ensuring optimal comfort and personalized therapy. By targeting both sides of the vagus nerve, Pulsetto aims to enhance the device’s overall therapeutic potential for stress, pain, and sleep-related conditions.

CONTRAINDICATIONS

  • Users with uncontrolled hypertension, hypotension, bradycardia, or tachycardia.

  • Users with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure, known severe coronary artery disease, or recent myocardial infarction (within 5 years).

  • Users with a history of abnormal baseline ECG, prolonged QT interval, or arrhythmia.

  • Users who have had surgery to cut the vagus nerve in the neck (cervical vagotomy).

  • Pediatric users.

  • Pregnant women.

  • Users with active cancer or cancer in remission.

  • Users with an abnormal cervical anatomy.

  • Users with a history of brain tumor, aneurysm, bleed, or head trauma.

  • Users with a history of syncope or seizures.

  • Users with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device.

  • Users with a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck.

  • Users who are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).

  • Users should not use Pulsetto:

    • While driving, operating machinery, or during any activity that may put the patient at risk of injury.

    • Near microwave machines, magnetic resonance imaging, radiofrequency surgical, or computer-aided tomography machines.

    • In an explosive atmosphere or in the presence of flammable gas mixtures.

    • If the user has an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the session location.

    • If the user has wet skin, is in the water, or just stepped out of the water (e.g., shower, bath, pool).

Recent Research with Pulsetto:

  • Evaluating the Efficacy of Bilateral Non-Invasive Vagus Nerve Stimulation in Reducing Migraine Symptoms: A Prospective Observational Study.

  • Evaluating Non-Invasive Vagus Nerve Stimulation for Pain Management in Bechterew Disease: A Pilot Study.

  • The effect of transcutaneous cervical vagus nerve stimulation on the cardiac autonomic nervous system.

More Research to Explore in Non-Invasive Vagus Nerve Stimulation Field:

  • Non-invasive Vagus Nerve Stimulation in Healthy Humans Reduces Sympathetic Nerve Activity - Brain Stimulation: Basic, Translational, and Clinical Research in Neuromodulation (brainstimjrnl.com).

  • Non-invasive vagus nerve stimulation boosts mood recovery after effort exertion | Psychological Medicine | Cambridge Core.

  • Noninvasive vagus nerve stimulation as acute therapy for migraine - PMC (nih.gov).

  • The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue and Immune Responses in Patients With Primary Sjögren’s Syndrome - Neuromodulation (neuromodulationjournal.org).

  • ScienceDirect Study.

  • Biorxiv Study.

  • ESMED Study.