March 2026 issue
March 31, 2026 | Migraine remains one of the most common and disabling neurological disorders worldwide. Despite the introduction of new pharmacologic treatments—including CGRP monoclonal antibodies and gepants—a substantial proportion of patients continue to experience inadequate symptom control, intolerance to medications, and desire non-pharmacologic treatment options.
Neuromodulation for the treatment of headache has been around for more than 25 years, with pioneers including Richard Weiner, who, along with Kenneth Reed, published in 1999 work describing subcutaneous occipital nerve stimulation for intractable occipital neuralgia (Weiner & Reed – 1999 Neuromodulation), and later Popeney and Alo proposed placing C1 through C3 peripheral leads to treat transformed migraine (Popeney & Alo – 2003 Headache).
Interest in developing occipital nerve stimulation systems lost momentum after the then “Big 3” neuromodulation companies—Medtronic (ONSTIM trial), Boston Scientific (PRISM trial), and St. Jude Medical—failed to meet their primary endpoints in headache trials.
Today’s migraine neuromodulation landscape is very different than 20 years ago, and includes a growing portfolio of noninvasive devices as well as several implantable systems designed specifically for migraine currently undergoing clinical evaluation. These technologies target multiple neural pathways implicated in migraine pathophysiology, including trigeminal, vagal, and occipital circuits.
While device-based therapies still represent a small segment of the migraine treatment market, their role is expanding as clinicians explore multimodal strategies.
A Growing Portfolio of Noninvasive Therapies
Several neuromodulation devices have received regulatory clearance in the U.S. for migraine treatment.
gammaCore, manufactured by electroCore is the U.S. commercial pioneer of noninvasive neuromodulation for headache disorders (including migraine). Co-founded in 2025 by Peter Staats and others, the gammaCore device first received FDA clearance in April 2017, originally for episodic cluster headache, followed later by acute migraine (2018). This handheld noninvasive vagus nerve stimulation delivers electrical pulses through the skin of the neck to stimulate the cervical vagus nerve.
One of the most commercially visible today is Nerivio, the remote electrical neuromodulation device developed by Theranica Bio-Electronics. The wearable device is placed on the upper arm and stimulates peripheral sensory nerves to activate endogenous descending pain inhibitory pathways.
The Cefaly system, developed by CEFALY Technology, provides external trigeminal nerve stimulation using an adhesive electrode applied to the forehead. The device, which is currently sold direct to consumers for $509 plus replacement electrodes, targets the supraorbital and supratrochlear branches of the trigeminal nerve and is typically used for preventive migraine therapy.
Meanwhile, Neurolief has introduced the Relivion MG system, a headset-based neuromodulation platform that stimulates both occipital and trigeminal nerve branches simultaneously. The system reflects growing interest in engaging multiple migraine-related neural pathways with a single device.
In the cortical stimulation category, eNeura has developed portable single-pulse transcranial magnetic stimulation devices designed for migraine treatment. Their SAVI Dual sTMS therapy is available through a monthly prescription, although per their website, insurance coverage is currently limited.
Collectively, these technologies illustrate the diversity of neuromodulation strategies currently being explored for migraine therapy.
Clinical Adoption Varies Widely
Despite the growing number of available devices, clinical adoption remains uneven.
Hsiangkuo (Scott) Yuan, Clinical Research Director at the Jefferson Headache Center at Thomas Jefferson University, notes that patient selection plays a major role in determining outcomes.
“Migraine is a spectrum. You have the easy cases who never reach specialty clinics and the very difficult cases we see every day,” Yuan said. “Among my patients—who represent the most refractory population—only a few are using these devices. For milder cases, they may work better.”
That observation highlights one of the central challenges in migraine noninvasive neuromodulation: devices may perform well in moderate disease but appear less effective in the complex patient populations treated at tertiary headache centers.
At the same time, clinicians emphasize that neuromodulation therapies generally have favorable safety profiles and can be used alongside pharmacologic treatments.
Increasingly, these devices are incorporated into multimodal migraine management strategies that combine medications, behavioral therapy, and lifestyle interventions.
Reimbursement: the Central Commercial Challenge
While clinical interest in neuromodulation continues to grow, reimbursement payment levels and coverage by private payors remains one of the most significant barriers to widespread adoption.
Unlike implantable neurostimulation systems used in chronic pain—which are reimbursed through established surgical payment frameworks as reasonably high payment levels (e.g. roughly $25K-$30K for trial, permanent lead and IPG implant at an ASC)—many migraine neuromodulation devices are prescribed for home use. In the case of electroCore’s gammaCore, the HCPCS code (K1020) was cross-walked to TENS devices for pricing purposes, or roughly $450 per patient (for a 13 month capped period).
Unlike many Medicare-covered technologies that have national payment rates set directly by the Centers for Medicare & Medicaid Services, reimbursement for HCPCS K1020 (non-invasive vagus nerve stimulator, used for electroCore’s gammaCore) is contractor-priced. CMS established the HCPCS code but did not assign a national DMEPOS fee schedule amount, leaving pricing to be determined by the regional Durable Medical Equipment Medicare Administrative Contractors across four jurisdictions. When a code is contractor-priced, the DME MACs establish the allowable payment amount within CMS guidelines rather than relying on a national fee schedule rate. As a result, reimbursement for K1020 may vary modestly by jurisdiction, with pricing typically informed by cross-walks to comparable devices such as TENS units (e.g., HCPCS E0720) referenced in the CMS coding decision. Because the code is contractor-priced, providers must consult the applicable DME MAC fee schedule or pricing determinations rather than the national CMS DMEPOS fee schedule to identify allowable payment levels.
The result of the low payment level for nVNS set by Medicare, coupled with non-coverage decisions by most private payors, has slowed commercial growth. However, gammaCore is gaining year-over-year traction and 2025 annual estimates, per electroCore, are expected to be at $32 million. The challenge lies on the CMS and private payor side, as per their most recent 10-Q, roughly 70% of Q1-Q3 2025 revenue came from VA/DOD sales.
On the private payor side, one notable exception has been Theranica’s Nerivio system, which has achieved significant traction with private insurers. According to the company, the device is now covered by payers representing roughly 130 million covered lives in the U.S.
However, the device has not obtained reimbursement from CMS. One reason is that the system does not meet the traditional definition of durable medical equipment—meaning a device must last 3 years to qualify for DME. The Nerivio device is prescribed for a limited number of treatments per unit (18 45-minute sessions), rather than functioning as a durable device intended for multi-year use.
Despite not qualifying for DME, the company has been highly successful on the private payor side, led by a strategy that has relied heavily on generating clinical and health-economic evidence to persuade private insurers that the device can reduce reliance on more costly migraine medications.
“They strategically did studies showing that using their device reduces the need for medications and may ultimately be cheaper than drug therapy,” Yuan noted.
This evidence-generation strategy has become a common pathway for device companies attempting to establish payer coverage.
Evidence Generation and the Role of Publication
Publication strategies continue to play an important role in building credibility for emerging medical technologies and supporting eventual reimbursement decisions. Companies developing neuromodulation therapies have increasingly invested in generating clinical and economic evidence to demonstrate both the biological rationale and real-world value of their devices. Theranica, for example, has produced a substantial number of publications examining the Nerivio device’s mechanism of action along with its clinical outcomes and potential economic benefits. Once these studies appear in the literature—even in smaller journals or as early online publications—they become part of the broader evidence base that companies can reference when engaging clinicians, payers, and policymakers.
At the same time, the growing volume of publications highlights ongoing debates surrounding evidence standards for device-based therapies. Clinical studies in neuromodulation frequently involve modest patient populations and varied trial designs, and constructing credible sham-control conditions remains technically challenging. These methodological issues have long complicated efforts to generate the level of evidence typically expected for pharmacological treatments. Nevertheless, the steadily expanding body of published research has helped strengthen the scientific foundation supporting neuromodulation as a therapeutic option for migraine.
A recent 2025 publication in Cephalalgia—“International Headache Society evidence-based guidelines on the use of non-invasive neuromodulation devices for the acute and preventive treatment of migraine,” authored by Hsiangkuo (Scott) Yuan, Stephen Silberstein, and colleagues—sought to establish formal clinical guidance for the use of noninvasive neuromodulation devices. The authors concluded that most of these devices available at the time received weak recommendations, citing limitations in study quality and statistical precision, as well as practical barriers related to device access and insurance coverage.
Implantable Systems Enter Clinical Trials
Although most commercial activity today centers on noninvasive technologies, implantable neuromodulation systems for migraine are once again attracting attention.
Two companies—ShiraTronics and Salvia BioElectronics—are currently developing implantable neurostimulation systems designed specifically for chronic migraine.
Both companies target the occipital nerve pathway, which feeds sensory input into the trigeminocervical complex. However, the two approaches differ in their stimulation strategies.
The ShiraTronics system focuses primarily on occipital nerve stimulation, targeting the greater occipital nerves located at the back of the head.
By contrast, Salvia BioElectronics is developing a system that stimulates both occipital and supraorbital nerves, aiming to influence multiple trigeminal pathways involved in migraine pain transmission.
According to Yuan, the devices also differ in how stimulation power is delivered.
“One design places the battery inside the body and can be programmed remotely, while the other uses an external power source that patients activate when they want stimulation,” he explained. “Each approach has advantages and disadvantages depending on patient preference and usability.”
Both companies are currently conducting clinical trials to evaluate the safety and effectiveness of their systems.
If successful, these technologies could revive interest in implantable neuromodulation for chronic migraine.
Patient Selection Remains Critical
One recurring theme in migraine neuromodulation research is the importance of patient selection.
Migraine is a heterogeneous disorder involving multiple neural networks and triggers, making it difficult to predict which patients will respond to a particular therapy.
Historically, implantable neuromodulation systems have been reserved for patients with severe chronic migraine who have failed multiple preventive treatments.
Noninvasive devices, by contrast, may be more appropriate earlier in the treatment pathway.
Clinicians increasingly emphasize the need for well-designed randomized controlled trials that follow standardized guidelines for neuromodulation research.
Such studies are critical not only for regulatory approval but also for payer acceptance.
Looking Ahead
Rapid technological innovation continues to shape the future of migraine neuromodulation. Advances in device miniaturization, wireless power transfer, and digital health integration are enabling more sophisticated stimulation platforms.
Researchers are also exploring closed-loop neuromodulation systems capable of detecting physiologic markers associated with migraine onset and automatically delivering therapeutic stimulation.
Artificial intelligence and machine-learning algorithms may further support personalized treatment strategies by identifying responder phenotypes and optimizing stimulation parameters.
If these technologies prove successful, neuromodulation may move earlier in the migraine treatment algorithm.
What This Means for Industry
Neuromodulation for migraine appears to be entering a new phase of development. Noninvasive devices have expanded the range of treatment options available to clinicians and patients, particularly for those seeking alternatives to pharmacologic therapies. At the same time, commercial adoption continues to be shaped largely by reimbursement dynamics and the strength of the clinical evidence base.
While most currently available devices have received relatively modest guideline recommendations, the growing body of published clinical data is gradually strengthening the scientific foundation for these technologies. Meanwhile, the emergence of new implantable systems from companies such as ShiraTronics and Salvia BioElectronics suggests that interest in device-based migraine therapy is extending beyond noninvasive approaches.
Taken together, these trends indicate that neuromodulation is likely to play an increasingly important role in migraine care—particularly as part of multimodal treatment strategies that combine devices with pharmacologic and behavioral therapies.
