Neuromodulation Devices Not FDA-Cleared for Both Acute and Preventive Migraine Treatment
Most neuromodulation devices for migraine are NOT FDA-cleared for both acute interventional and preventive treatment—in fact, noninvasive devices that stimulate the occipital and trigeminal nerves have demonstrated efficacy specifically in the acute treatment of migraines, but no noninvasive modality has been studied or approved for preventive treatment. 1
FDA Regulatory Status of Neuromodulation Devices
Current Approval Landscape
No permanent neuromodulation device has received FDA approval for the treatment of pain in the craniofacial region 1
Multiple wireless peripheral nerve stimulation (PNS) systems have received FDA approval for treatment of pain in the trunk and extremities, with one device recently receiving an expanded indication for treatment of headache and axial neck pain 1
Noninvasive devices stimulating occipital and trigeminal nerves have been developed with efficacy demonstrated in acute migraine treatment, but no noninvasive modality has been studied specifically for preventive applications 1
Specific Device Examples
Remote Electrical Neuromodulation (REN):
- Nerivio® is FDA-authorized specifically for acute treatment of migraine with or without aura in people 12 years and older 2
- This device is effective for acute treatment but is not cleared for preventive use 3
Transcranial Direct Current Stimulation (tDCS):
- The 2023 VA/DoD guidelines found insufficient evidence to recommend for or against tDCS for either acute or preventive migraine treatment 1
- Cathodal tDCS over the primary motor cortex showed no significant effect for prevention 3
Evidence Quality and Clinical Implications
Guideline Recommendations
The 2023 VA/DoD headache guidelines concluded that:
- There is insufficient evidence to recommend for or against any form of neuromodulation for the abortive or preventive treatment of migraine 1
- Studies assessing acute migraine treatment have recorded inconsistent outcomes 1
- Studies examining migraine prevention have had small sample sizes 1
Important Clinical Caveats
When considering neuromodulation as a treatment option, clinicians should be aware of:
- Contraindications for each type of therapy 1
- Differences in the frequency of treatment duration between devices 1
- Differences within the same device dependent on whether the acute or preventive setting is being used 1
Invasive vs. Noninvasive Distinction
Invasive occipital nerve stimulation (ONS):
- Effective for migraine prevention with large effect size but considerable heterogeneity 3
- Requires off-label use of neurostimulation devices in the United States 1
Noninvasive devices:
Practical Answer to the Question
The answer depends on which specific device you're asking about, but the pattern is clear: most neuromodulation devices are cleared for either acute OR preventive treatment, not both. Noninvasive devices like those stimulating occipital and trigeminal nerves are cleared for acute treatment but have not been studied or approved for prevention 1. Conversely, invasive ONS has evidence for preventive treatment but lacks robust data for acute intervention 3.