Vagus nerve stimulation (VNS) uses controlled electrical pulses to modulate the activity of the vagus nerve — the body’s longest cranial nerve and the primary channel of the parasympathetic nervous system. What began as a single implanted device for epilepsy has expanded into a family of technologies that now treat conditions ranging from migraine and depression to rheumatoid arthritis and stroke recovery. This guide covers every current type of VNS device, how each works, and where the field is heading.
How Vagus Nerve Stimulation Works
The vagus nerve carries signals between the brainstem and most major organs, regulating heart rate, digestion, inflammation, and mood. VNS devices deliver mild electrical impulses to the nerve, which travel to the brainstem and influence the release of neurotransmitters including norepinephrine, serotonin, and acetylcholine. These changes can reduce seizure activity, dampen inflammation, modulate pain signaling, and promote neural plasticity — depending on the stimulation parameters and the target condition.
All VNS devices share this basic mechanism, but they differ in three important ways: where they stimulate the nerve (neck, ear, or directly on the nerve trunk), whether they require surgical implantation, and whether the stimulation runs continuously or is triggered by specific events.
Implanted VNS Devices
Implanted VNS remains the gold standard for drug-resistant epilepsy and treatment-resistant depression. A small pulse generator — roughly the size of a stopwatch — is surgically placed under the skin of the upper chest, with a thin lead wire threaded up to the left vagus nerve in the neck. The procedure typically takes one to two hours under general anaesthesia.
LivaNova VNS Therapy
LivaNova’s VNS Therapy system is the most widely used implanted VNS device worldwide. Its current-generation SenTiva and SenTiva Duo generators can be programmed by clinicians and adjusted remotely. The system delivers stimulation on a preset duty cycle — typically 30 seconds on and five minutes off — around the clock.
FDA-approved indications include adjunctive treatment of drug-resistant epilepsy (approved since 1997) and treatment-resistant depression (since 2005). Clinical data show that seizure frequency continues to decrease over time, with many patients experiencing a 50% or greater reduction in seizures after two years. For depression, VNS has demonstrated sustained improvement in patients who have not responded to multiple antidepressant medications.
SetPoint Medical — The SetPoint System
In 2025, the FDA approved the SetPoint System — the first VNS device indicated for an autoimmune condition. Developed by SetPoint Medical, it targets moderate-to-severe rheumatoid arthritis in adults who have not responded adequately to biologic or targeted synthetic disease-modifying drugs (DMARDs).
The SetPoint System is a miniaturised implant placed during a minimally invasive outpatient procedure. It delivers stimulation to the vagus nerve once daily on a predetermined schedule, activating the cholinergic anti-inflammatory pathway — a neural circuit in which vagus nerve signals trigger the spleen to reduce production of pro-inflammatory cytokines including TNF-alpha, IL-1, and IL-6.
In the pivotal RESET-RA trial — a randomised, double-blind, sham-controlled study of 242 patients — the device met its primary endpoint (ACR20 response at three months), and improvements continued through 12 months. Notably, 75% of patients were free of biologic or targeted synthetic DMARDs at one year. Serious adverse events related to therapy occurred in just 1.7% of patients, with no therapy-related malignancies, major cardiac events, or serious infections. The device received FDA Breakthrough Device Designation and is designed to deliver therapy for up to 10 years without replacement.
This approval marks a milestone for bioelectronic medicine — the principle that electrical signals to nerves can replace or supplement pharmaceutical drugs for inflammatory and autoimmune conditions.
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Non-Invasive VNS Devices
Non-invasive VNS delivers stimulation through the skin without surgery. Two approaches are now in clinical use.
gammaCore (Neck Stimulation)
gammaCore, made by electroCore, is a handheld device that delivers non-invasive VNS through the skin of the neck, over the vagus nerve. It is prescription-only and FDA-cleared for six headache indications in adults: preventive and acute treatment of migraine (including adolescents aged 12 and over), adjunctive preventive and acute treatment of episodic cluster headache, and treatment of hemicrania continua and paroxysmal hemicrania.
To use the device, the patient applies a conductive gel to the stimulation surfaces, places it against the neck over the vagus nerve, and increases intensity until they feel a tingling sensation. A standard treatment is two two-minute stimulations on one side of the neck. For prevention, this is done twice daily; for acute attacks, it can be used as needed. The current-generation gammaCore Sapphire is designed for improved ergonomics and portability.
Transcutaneous Auricular VNS (taVNS)
Transcutaneous auricular vagus nerve stimulation targets the auricular branch of the vagus nerve — the only branch that surfaces at the skin, specifically at the cymba conchae and tragus of the outer ear. This approach uses small ear-clip or earbud-style devices to deliver low-level electrical stimulation.
Clinical research on taVNS has accelerated significantly. Active trials are investigating taVNS for conditions including insomnia, anxiety, depression, post-traumatic stress disorder, acute stress responses, chronic pain, and inflammation. Consumer-oriented taVNS devices such as Nurosym and Pulsetto have entered the market, though these are positioned as wellness devices rather than medical treatments, and their clinical evidence base is still developing compared to prescription VNS systems.
The appeal of taVNS lies in its accessibility — ear stimulation is painless, requires no prescription in most markets, and can be self-administered at home. However, standardisation of stimulation parameters (frequency, pulse width, intensity, duration) across devices and conditions remains an open question in the research.
Paired VNS for Stroke Rehabilitation
One of the most innovative applications of VNS is paired stimulation — short bursts of vagus nerve stimulation delivered at the precise moment a patient performs a rehabilitation movement. The principle is that VNS triggers the release of neuromodulators (acetylcholine and norepinephrine) that enhance synaptic plasticity, and pairing this release with specific motor tasks strengthens the neural pathways being retrained.
MicroTransponder’s Vivistim Paired VNS System received FDA approval in 2021 for chronic ischaemic stroke patients with moderate-to-severe upper extremity impairment. The system consists of an implanted pulse generator and lead wire, similar to traditional VNS, but stimulation is delivered by a therapist during rehabilitation exercises rather than continuously.
In the VNS-REHAB pivotal trial published in The Lancet, patients receiving paired VNS showed three-fold greater improvement in arm and hand function compared with intensive rehabilitation alone, and 65% reported clinically significant improvement in their ability to perform daily activities. Active multisite trials continue to evaluate paired VNS for broader stroke populations and extended follow-up.
Emerging Technologies
Closed-Loop VNS
Current VNS devices deliver stimulation on fixed schedules regardless of what the body is doing at that moment. Closed-loop systems aim to change this by monitoring physiological signals — heart rate, EEG, or vagal nerve activity itself — and delivering stimulation only when it is needed. Early feasibility studies are underway, with the goal of maximising therapeutic benefit while minimising unnecessary stimulation and side effects. This approach could be particularly valuable for epilepsy, where stimulation timed to pre-seizure neural signatures might prevent seizures more effectively than continuous cycling.
Miniaturised and Wireless Implants
The trend across all implanted VNS devices is toward smaller generators, longer battery life, wireless programming, and less invasive surgical placement. The SetPoint System already demonstrates this trajectory — its miniaturised implant is placed in an outpatient procedure and operates autonomously for up to a decade. Future devices may eliminate the chest-mounted generator entirely, with tiny electrodes powered wirelessly from outside the body.
Who Is a Candidate for VNS?
Candidacy depends entirely on the device and the condition being treated. Implanted VNS for epilepsy is typically considered after a patient has tried and not responded to at least two anti-seizure medications. For treatment-resistant depression, multiple failed antidepressant trials are usually required. The SetPoint System requires documented failure of or intolerance to biologic or targeted synthetic DMARDs for rheumatoid arthritis. Paired VNS for stroke requires chronic ischaemic stroke with moderate-to-severe upper limb impairment.
gammaCore is prescribed for patients with migraine, cluster headache, hemicrania continua, or paroxysmal hemicrania. It is not recommended for people with active implanted electronic devices such as pacemakers.
Consumer taVNS devices are generally available without prescription, but anyone with a cardiac condition, implanted device, or seizure disorder should consult a healthcare provider before use.
What to Expect
For implanted devices, the surgical procedure is straightforward — typically one to two hours, often as an outpatient. Recovery involves some discomfort around the incision site for one to two weeks. Common side effects of implanted VNS include temporary hoarseness, coughing, or tingling during stimulation. These are usually mild and often decrease over time.
Non-invasive devices have minimal side effects. gammaCore may cause a pulling sensation at the lip during use, and taVNS devices may cause mild tingling or skin irritation at the ear. Serious adverse events with any form of VNS are rare.
All implanted VNS devices require ongoing follow-up with a specialist to optimise stimulation settings. Non-invasive devices can usually be managed by the patient, with periodic check-ins with a prescribing clinician.
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