TMS Therapy For Migraine Headaches
38%
PAIN-FREE AT 2 HOURS
Of patients using TMS were pain-free at 2 hours in FDA clinical trial
34%
Pain-free at 24 hours after TMS treatment
2013
Year FDA first cleared Cerena TMS for acute migraine with aura
18
Minimum age for FDA-cleared TMS migraine treatment
24
Hours required between TMS treatments (once per day maximum)
FDA Clearance for Migraine TMS
Millions of Americans suffer from migraines, with attacks lasting 4 to 72 hours when untreated. Many patients experience inadequate relief from conventional medications or cannot tolerate side effects from triptans, anti-epileptics, or beta-blockers.
In December 2013, the FDA granted marketing clearance to the Cerena Transcranial Magnetic Stimulator through the de novo premarket review pathway. This made it the first medical device cleared to relieve pain caused by migraine headaches that are preceded by an aura. The FDA's Center for Devices and Radiological Health stated that this new device represents a new treatment option for millions of migraine sufferers.
In May 2014, eNeura received subsequent clearance for the SpringTMS device, which uses the same single-pulse TMS therapy with improved portability. Both devices are prescription-only and intended for self-administration at home.
FitMind Therapeutics offers TMS therapy for migraine headaches in Jacksonville, FL, using clinical TMS systems for patients who qualify. Device self-administration is not currently available through our clinic.
Clinical Picture: Migraine With and Without Aura
Migraine is a complex neurological disorder characterized by recurrent headache attacks accompanied by specific features. TMS has received FDA clearance specifically for migraine with aura.
Migraine With Aura:
Visual disturbances such as flashing lights, zigzag lines, or blind spots before or during headache
Sensory aura including tingling or numbness spreading from one body part to another
Speech or language aura such as difficulty finding words
Aura phase typically lasts 5 to 60 minutes
TMS works by disrupting cortical spreading depression during the aura phase
Migraine Without Aura:
Headache without preceding visual or sensory symptoms
May still have associated symptoms including nausea, light sensitivity, and sound sensitivity
Typically unilateral with throbbing pain
Attacks last 4 to 72 hours when untreated
TMS is not FDA-cleared for this subtype
What is cortical spreading depression? This is a wave of altered electrical activity that travels across the cerebral cortex at 2 to 6 millimeters per minute. It is the underlying neurological event that produces the migraine aura. Single-pulse TMS delivered early in the aura phase can disrupt this wave, potentially aborting or reducing the subsequent headache.
Important clinical note: The FDA pivotal trial for Cerena TMS enrolled patients who had auras preceding at least 30 percent of their migraines. TMS for migraine is cleared for ages 18 and older only.
How TMS Therapy Stops Migraine
TMS delivers highly focused, brief pulses of magnetic energy through a coil placed on the scalp. This induces small electrical currents in specific brain regions without surgery or anesthesia.
For acute migraine with aura, the patient uses both hands to hold the device against the back of the head. The patient presses a button to release a very short magnetic pulse lasting less than one second. This stimulates the brain's occipital cortex, which is the back part of the brain that processes visual information.
The magnetic pulse depolarizes neurons and interrupts the abnormal hyperactivity linked with the occurrence of migraine. By disrupting cortical spreading depression early in the aura phase, TMS may abort or reduce the severity of the subsequent headache.
Mechanism Summary:
Single pulse delivered at first sign of aura or when pain begins
Generates electrical current in occipital cortical neurons
Interrupts cortical spreading depression wave
May abort or reduce subsequent headache
Clinical Evidence: What The Data Shows
FDA Pivotal Trial — 201 Patients
The FDA’s marketing clearance was based on a randomized controlled clinical trial involving 201 patients. These patients had mostly moderate to strong migraine headaches and had auras preceding at least 30 percent of their migraines. Of the study subjects, 113 recorded treating a migraine at least once when pain was present.
Results:
38 percent of patients using TMS were pain-free at 2 hours
34 percent of patients using TMS were pain-free at 24 hours
Important limitations documented by the FDA:
The study did not show that TMS is effective in relieving associated migraine symptoms including light sensitivity, sound sensitivity, and nausea
The device is approved only for use by those aged 18 or older
2025 Meta-Analysis Findings
A comprehensive meta-analysis of non-invasive brain stimulation for migraine evaluated both short-term and long-term efficacy. The analysis found significant short-term benefits for headache frequency reduction, pain intensity reduction, and pain duration. The analysis also found significant reduction in analgesic medication use.
However, the analysis identified important limitations in long-term efficacy. No significant improvements were detected at 3 to 6 months follow-up. The authors concluded that while non-invasive brain stimulation is an effective preventive and safe treatment for migraine in the short term, its long-term efficacy is not evident.
Safety, Side Effects, and Contraindications
Side Effect Profile
TMS is generally well-tolerated. The FDA noted in its clearance that there had been single cases of sinusitis, aphasia (inability to speak or understand language), and vertigo (sensation of spinning) in the device’s trials. Dizziness may be associated with use of the device.
Side Effect
Mild scalp discomfort
Dizziness
Vertigo
Aphasia
Sinusitis
Notes
Local sensation during magnetic pulses
May be associated with device use
Single case reported in FDA trials
Single case of temporary speech difficulty
Single case reported in FDA trials
Absolute Contraindications
TMS should not be used by anyone with:
Any metal device implanted in the head, neck, or upper body
An active implanted medical device such as a pacemaker or deep brain stimulator
Family history of seizures
Suspected or diagnosed epilepsy
Age Restriction
The FDA-cleared TMS device is approved only for use by individuals aged 18 or older.
Usage Limit
The recommended daily usage of the device is not to exceed one treatment in 24 hours.
Migraine Headaches Treatment Comparison
Feature
FDA clearance for migraine
Invasiveness
Administration
Onset of action
Systemic side effects
Works when medications fail
Risk of medication overuse headache
Usage limits
TMS for Migraine
Yes for migraine with aura
Non-invasive
Self-administered at home
Minutes during aura
None
Yes
None
Once per 24 hours
Triptans
Yes
Systemic medication
Self-administered
30 to 60 minutes
Chest tightness, nausea, dizziness
No
Yes
2 to 4 days per week maximum
CGRP Antagonists
Yes
Systemic medication
Self-administered
1 to 2 months
Constipation, injection site reactions
No
Low
None
Frequently Asked Questions
What is TMS therapy for migraine headaches?
Transcranial Magnetic Stimulation is a non-invasive procedure that uses focused magnetic pulses to stimulate specific brain regions involved in migraine. Single-pulse TMS is FDA-cleared for acute treatment of migraine with aura.
Is TMS FDA-approved for migraine?
Yes for migraine with aura. The Cerena Transcranial Magnetic Stimulator received FDA clearance in December 2013. The SpringTMS device received clearance in May 2014. No TMS device is currently FDA-cleared for migraine without aura.
How does TMS stop a migraine attack?
Yes for migraine with aura. The Cerena Transcranial Magnetic Stimulator received FDA clearance in December 2013. The SpringTMS device received clearance in May 2014. No TMS device is currently FDA-cleared for migraine without aura.
What is the success rate of TMS for migraine?
In the FDA pivotal trial, 38 percent of patients using TMS were pain-free at 2 hours and 34 percent were pain-free at 24 hours.
How many TMS sessions are needed for migraine?
For acute treatment, TMS is applied at the first sign of each aura episode. The device may be used once per 24 hours. No ongoing sessions are required between attacks.
What are the side effects of TMS for migraine?
Side effects are generally mild. The FDA reported single cases of sinusitis, aphasia, and vertigo in trials. Dizziness may be associated with device use.
Is TMS for migraine safe for people with epilepsy?
No. The FDA-cleared TMS device should not be used by people with suspected or diagnosed epilepsy or a family history of seizures.
What are the contraindications for TMS migraine treatment?
The device should not be used by anyone with any metal device implanted in the head, neck, or upper body; an active implanted medical device such as a pacemaker or deep brain stimulator; suspected or diagnosed epilepsy; or family history of seizures. The device is also only approved for ages 18 and older.
Does TMS cure migraine?
No. TMS is not intended to provide a cure for migraine and reduction in symptoms may be modest. Research also shows that long-term efficacy is not evident.
Does TMS work for migraine without aura?
The FDA-cleared TMS device is specifically indicated for migraine with aura. The pivotal trial enrolled patients who had auras preceding at least 30 percent of their migraines.
Will insurance cover TMS for my migraines?
Coverage varies. TMS for migraine with aura may be covered by some commercial insurers with prior authorization. FitMind Therapeutics will verify benefits before treatment begins.
What is the minimum age for TMS migraine treatment?
The FDA-cleared TMS device is approved only for use by individuals aged 18 or older.
How often can I use TMS for migraines?
The recommended daily usage of the device is not to exceed one treatment in 24 hours.
Next Steps
If you suffer from migraine with aura and have not found adequate relief with medications, or if medication side effects have been intolerable, TMS offers a proven, drug-free alternative.
Hours:
Office visits: Monday–Friday, 9:00 AM – 5:00 PM
TMS treatments: Monday–Friday, 9:00 AM – 5:00 PM
Saturday–Sunday: Closed
Languages: English, Russian, Ukrainian
HIPAA-Compliant E-Fax for Referrals: (904) 659-8380
Insurances We Accept
Find Your Path to Wellness With Advanced TMS Sessions in Jacksonville
Depression can make it difficult to enjoy the things you love in life, but there is hope for a better future. If your depression symptoms have not responded to your attempts at treatment, NeuroStar Advanced TMS Therapy in Jacksonville may be a good fit for you.
Our providers at Fit Mind Therapeutics are here to help. Schedule a consultation with our team today to determine whether TMS is the next step in your treatment plan.
Our HIPAA-compliant E-Fax number for referrals is (904) 659-8380.
Please include the following minimal patient information: first/last name, DOB, address, contact number/email, diagnosis, insurance and policy number, and name of referring provider.
Insurance Coverage Notice
TMS therapy is typically covered by most major insurance plans for the treatment of Major Depressive Disorder (MDD). If you're unsure whether your insurance covers your treatment, please contact us, and we'll be happy to verify your benefits on your behalf. For conditions that are not covered by insurance, we'll work with you to discuss alternative treatment and payment options.