FAQs

Indication and Patient Selection
Can Nerivio be used alongside migraine medications?

Yes. Nerivio may be used either as standalone therapy or alongside pharmacologic migraine treatments. Because Nerivio is a non-drug therapy, there are no systemic side effects and no drug-drug interactions associated with its use. 

Providers may incorporate Nerivio into individualized treatment plans that include preventive therapies, acute medications, behavioral interventions, or multimodal migraine management strategies.

Which patients may be appropriate candidates for Nerivio?

Nerivio may be appropriate for a broad range of migraine patients*, including:

  • Adolescents and pediatric patients 8 years of age and older
  • Women who are or may become pregnant
  • Patients seeking non-pharmacological treatment options
  • Patients who cannot tolerate medication, swallowing pills, and injections 
  • Patients who prefer to avoid medication side effects
  • Patients with chronic or episodic migraine
  • Patients requiring both acute and preventive treatment options
  • Patients concerned about medication burden or medication overuse
  • Patients seeking drug-free treatment approaches alongside pharmacologic therapy
Is Nerivio indicated for patients with chronic migraine?

Yes. Nerivio is indicated for both chronic and episodic migraine in patients 8 years of age and older.

Who is Nerivio indicated for?

Nerivio is a prescription-use, self-administered remote electrical neuromodulation (REN) device cleared by the FDA for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age and older. For acute treatment, Nerivio should be used at the onset of migraine headache or aura. For preventive treatment, Nerivio is used every other day. 

Mechanism of Action & Clinical Evidence
What outcomes have been demonstrated in preventive treatment studies?

Clinical studies evaluating preventive use of Nerivio demonstrated reductions in monthly migraine days after consistent every-other-day treatment over a two-month period. 

Providers should counsel patients that preventive benefit requires ongoing adherence to the prescribed treatment schedule. 

What clinical evidence supports Nerivio?

Nerivio has been evaluated across multiple clinical studies and real-world analyses in patients with chronic and episodic migraine, including adult, adolescent, and pediatric populations.

Clinical studies evaluating preventive treatment with Nerivio demonstrated:

  • Reduction of 4.0 monthly migraine days after 8 weeks (P <.001)
  • 50% responder rate for moderate-to-severe headache days in 51.6% of patients (P = .033)
  • Reduction in acute medication use days by 3.5 days per month (P = .001)

Clinical studies evaluating acute treatment with Nerivio demonstrated:

  • Pain relief at 2 hours post-treatment in 66.7% of patients (P < .0001)
  • Pain freedom at 2 hours post-treatment in 37.4% of patients (P = .003)
  • Improvement in functional outcomes and associated symptoms

Preventive treatment studies demonstrated reductions in monthly migraine days following consistent every-other-day use.

Additional real-world evidence has supported the safety and tolerability of repeated and frequent use.

Click here to view our growing body of clinical evidence.

How is Nerivio different from a TENS unit?

Although both devices deliver electrical stimulation, Nerivio and traditional TENS devices utilize different mechanisms of action and stimulation sites.

TENS devices primarily act through localized pain inhibition mechanisms and are typically applied at the site of pain. 

Nerivio’s REN mechanism stimulates peripheral nerves in the upper arm to activate conditioned pain modulation, a centrally mediated pain inhibitory process that delivers widespread pain modulation.

How does remote electrical neuromodulation (REN) work?

Nerivio providers non-invasive stimulation to peripheral nerves in the upper arm to active an endogenous analgesic mechanism known as conditioned pain modulation (CPM). 

The stimulation activates descending pain inhibitory pathways within the brainstem, producing a systemic pain inhibitory response that modulates migraine pain processing.

Safety and Tolerability
Do patients discontinue Nerivio because of side effects?

Discontinuation rates due to adverse events have been low in both clinical and real-world settings. Reported adverse events are typically mild, transient, and self-resolving.

Does frequent use increase safety risk?

Available real-world evidence suggests that frequent use of Nerivio does not increase adverse event risk. Reported side effect rates remained low and consistent with prior clinical findings, even among patients using the device multiple times per day.

Can patients use Nerivio multiple times per day?

Yes. Real-world safety analyses involving more than 1,800 patients demonstrated low adverse event rates and no serious safety signals, even among patients using Nerivio multiple times per day. 

These findings support flexible treatment use in patients with frequent, severe, or recurring migraine attacks, consistent with provider guidance.

What adverse events have been observed with Nerivio?

Nerivio has demonstrated a favorable safety and tolerability profile across clinical and real-world studies.

The most commonly reported adverse events are mild, transient, and localized to the treatment area, including: 

  • Temporary arm discomfort
  • Skin irritation or redness
  • Tingling or numbness sensations

No systemic adverse events associated with treatment have been observed. No serious device-related adverse events were reported in clinical studies or real-world analyses.

What contraindications and precautions should providers be aware of?

Nerivio should not be used in patients with:

  • Uncontrolled epilepsy
  • Activate implantable medical devices, including pacemakers, hearing aid impacts, or other implanted electronic devices

The device should only be applied to the upper arm over dry, healthy skin with normal sensation and without metallic implants or proximity to cancerous lesions.

Providers should review the full Instructions for use prior to prescribing.

Nerivio has not been evaluated in people with congestive heart failure (CHF), severe cardiac or cerebrovascular disease, or those under the age of 8. Nerivio should only be applied on the upper arm over dry, healthy skin, with normal physical sensation and away from proximity to cancerous lesions. Do not use the device on an arm with a metallic implant. In such cases, consider using it on the other upper arm. Use the device according to user and healthcare provider instructions. If treating more than once a day, wait 30 minutes and switch arms between treatments. Administering treatment more than 6 times per day is unlikely to provide any additional benefit.

Treatment Guidance
3 Pillars for Optimal Preventive Treatment

1. Treat Every-Other-Day

For optimal results, patients should follow the every-other-day treatment plan. This means 3 Nerivio treatments per week. 

2. Treat consistently for at least three months to see results

Based on International Headache Society (IHS) guidelines, preventive treatment needs at least 3 months of regular use before its effectiveness can be evaluated.

If a patient skips a treatment, they should complete it as soon as possible. The Nerivio-app issues reminders to help patients treat on time.

3. Set treatment intensity to be strongly felt, but not painful

Set the treatment intensity to be strongly felt, but not painful, just below your pain threshold. If a patient stops feeling the stimulation during treatment, they should slightly increase the intensity until it is clearly felt again.

3 Pillars for Optimal Acute Treatment

1. Treat as early as possible 

For optimal results, patients should start the treatment as soon as they experience the first symptoms of a migraine attack (such as headache or aura).  

Studies show that initiating Nerivio treatment as early as possible, at the onset of migraine symptoms, can double clinical efficacy.

2. Set treatment intensity to be strongly felt, but not painful 

For optimal results, set the treatment intensity to be strongly felt, but not painful, just below your pain threshold. If patients stop feeling the stimulation during treatment, they should slightly increase the intensity until it is clearly felt again. 

In clinical trials, users who treated at 25%–50% intensity often saw the best results. But intensity is personal; there’s no correct number. If increasing to 25% intensity feels too strong, that’s ok. If patients clearly feel the stimulation, they are set.

3. Repeat treatment when needed

If needed, you may treat more than once a day, even consecutively, as directed by your healthcare provider. 

If treating back-to-back, patients should wait 30 minutes and switch arms between two consecutive treatments. Administering treatment more than 6 times per day is unlikely to provide further benefit.

Practice & Prescribing Information
What should providers counsel patients to expect during treatment?

Patients will experience a strong but tolerable electrical stimulation sensation on the upper arm during treatment. The sensation typically becomes less noticeable after the first few minutes of therapy.

Some patients may experience temporary warmth, tingling, numbness, redness, or arm soreness at the application site, which generally resolves shortly after treatment completion.

What support resources are available for patients?

Nerivio offers patient support resources that include onboarding assistance, refill support, device troubleshooting, and insurance support through Nerivio Cares, available at support@nerivio.com or 1-866-637-4846 Mon-Fri 8am-8pm EST.

What Nerivio device models are available?

Nerivio is available by prescription only in multiple device configurations, including:

  • Nerivio disposable device (VA patients only)
  • Nerivio Infinity rechargeable device with replaceable electrode pads (all other patients)

Outside the US, availability may vary by region. Click here for more information on Nerivio’s availability.

Insurance Coverage
Is Nerivio covered by insurance?

Yes! Nerivio is the only non-drug, cleared by FDA migraine therapy that has widespread commercial insurance with commercial payers (as well as the VA). Nerivio is eligible for insurance coverage. Insurance coverage differs by individual. You can check coverage per specific insurance plan here.

Behavioral Support & Digital Features
What is GIER and how is it used with Nerivio?

The Nerivio app includes an optional behavioral support feature called Guided Imagery, Education, and Relaxation (GIER).

GIER is designed to complement Nerivio’s REN therapy through guided audio-visual behavioral interventions focused on relaxation and migraine education. Research suggests that combining behavioral support with REN therapy further improves migraine relief outcomes in patients. In a clinical study, patients who used GIER during Nerivio treatment sessions reported a 14.5% higher rate of relief compared to their REN-only counterparts.

Patients may access GIER during either acute or preventive treatment sessions through the Nerivio app.

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