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SpringTMS Transcranial Magnetic Stimulation Device for Migraine Receives FDA Approval

Spring TMS, the first transcranial magnetic stimulation device for migraine that will be available to U.S. patients, has received FDA approval.1 The details are sparse, but here’s what I know so far.

Is it for migraine with aura or without?

Spring TMS, which is manufactured by eNeura, has been approved for use in people who have migraine with aura. This is not just visual aura, but a visual, sensory or motor disturbance that immediate precedes the migraine attack. (This may change. See “When will SpringTMS be available” for details.)

Is it for chronic or episodic migraine?

Patients who have between one and eight migraine attacks per month were included in the study that the approval was based on. (This may change. See “When will SpringTMS be available” for details.)

When will SpringTMS be available?

Before it becomes available to patients, SpringTMS will be part of a pilot study to determine the device’s optimal use. The study is expected to begin early this summer. In January, my headache specialist told me the plan was to conduct the study with about 600 patients spread across six different U.S. headache clinics. He expected the study would last about six months.

A similar pilot study was conducted in England after the SpringTMS was approved by the E.U. That study included patients who had migraine with aura and migraine without aura. It also included patients with episodic and chronic migraine. It is possible the pilot study will be conducted the same way in the U.S.

How can patients get the device?

During the pilot study, qualifying patients at the yet-unnamed headache clinics will be considered for inclusion in the study. If you’re interested in participating in the study, email customercare@eneura.com and ask to be placed on the list.

After the pilot study, SpringTMS will be available by prescription only.

How much will it cost?

The device will be available for rental only and it will cost $250 a month.

Will it be covered by insurance?

Likely, but when and for whom is yet unknown. According to eNeura’s CEO David Rosen, “As a new migraine treatment insurance coverage for SpringTMS will vary and likely require documentation of medical necessity from the prescribing physician.”

Insurance may only cover it for people who match the population of the study that it’s approval was based on (one to eight migraine attacks a month that are preceded by a visual, sensory or motor aura at least 30% of the time). The findings of the pilot study may open it up to a wider group.

What’s the research?

The study used for FDA’s approval included 201 patients who had a visual, sensory or motor aura before at least 30% of their attacks. 38% who used the device during a migraine were pain-free two hours after using the device. After 24 hours, 34% were pain-free (only 10% who used a sham device were pain-free after 24 hours). This was a high quality, double-blind, placebo-controlled, randomized clinical study that took place in 18 U.S. headache clinics.3

In the pilot study in England:

  • 73% of patients reported partial or complete pain relief.
  • 53% reported a reduction in the number of headache days.
  • 63% reported a reduction in non-pain migraine symptoms.
  • 17% reported improved sleep quality.

These improvements continued throughout and beyond the three-month study period.4

What are the side effects?

Very few adverse effects were recorded in the study and no patient dropped out of the study because of them.

  • Headache –SpringTMS: 2 patients, Sham: 1 patient
  • Migraine – SpringTMS: 2 patients, Sham: 0 patients
  • Sinusitus – SpringTMS: 2 patients, Sham: 1 patient
  • Tingling, burning or itching of skin – SpringTMS: 0 patients, Sham: 2 patients

These are minor reactions that could be due to coincidence rather than the device itself.

How does it work?

Single-pulse transcranial magnetic stimulation (sTMS) induces very mild electrical currents. These currents depolarizes neurons in the brain, which is thought to interrupt the hyperactivity in the migraine brain.

How do you use it?

As soon as you notice a migraine coming on, you put the device – which is a small box with two handles – at the back of your head and push a button. That generates a focused magnetic pulse that passes through is intended to interrupt the migraine.

Does it hurt?

There is no perceptible sensation associated with using the device. It does not cause pain.

What about the Cerena TMS device the FDA approved in December?

SpringTMS is a smaller, easier-to-use version of the Cerena. Cerena will not be available to patients. It’s approval paved the way for the SpringTMS’s approval.

Note: This post was updated to reflect the most accurate availability and pricing information as of June 2, 2014. Updated information is based on an interview with eNeura CEO David Rosen.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The Migraine.com team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

  1. eNeura, Inc. Receives FDA Clearance for SpringTMS Migraine Treatment Device. Press release via Yahoo Finance. May 23, 2014. Retrieved May 23, 2014 from http://finance.yahoo.com/news/eneura-inc-receives-fda-clearance-120100623.html.
  2. New NICE guidance on Transcranial Magnetic Stimulation. Migraine Action. Jan. 22, 2014. Retrieved May 23, 2014 from http://www.migraine.org.uk/latest-news/new-nice-guidelines-on-transcranial-magnetic-stimulation/
  3. Lipton, Richard B., et al. "Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial." The Lancet Neurology 9.4 (2010): 373-380.
  4. Weatherall, M. W., et al. "Post market pilot programme with single pulse transcranial magnetic stimulation (sTMS) for acute treatment of migraine: SpringTMS™ use in migraine." The journal of headache and pain 14.Suppl 1 (2013): P222.

Comments

  • Fred
    4 years ago

    Dr. Young from Jefferson prescribed it for me today. I just sent the paperwork to eNeura – was a fairly easy process. You pay eNeura up front. eNeura contacts your insurance company to try and get some reimbursement…they made no promises. I have resigned myself to 100% out of pocket at anyway.

    This is my first post so hello to everyone. I’ve done a lot of reading on here but never felt I had anything to add. For background, I’ve done the medications/injections/inpatient infusion things we all know too well. I’m still at 20-25 migraines a month for the last 3 yrs. I figure Spring TMS is worth a shot, albeit a very expensive one.

    I should have the device in 3-5 days. I will post my experience.

  • jns192 moderator
    4 years ago

    Fred,
    Thank you so much for sharing your experience.
    We have a forum on “magnetic treatment” and your experience with STMS might be helpful to other community members.
    If you’d like, feel free to post here: https://migraine.com/topic/magnetic-treatment/
    Have a great night,
    Jillian (Migraine.com Team)

  • Fred
    4 years ago

    I have been using the STMS device for 5 days. There’s no discernible change in how I feel but I thought I’d give a report on my experience so far.

    The device is easy to use – turn it on and press a button to prepare the treatment. When it’s ready it beeps – hold it to the back of your head and press the buttons on each handle. You hear and feel a knock which may have been startling if the instructions hadn’t prepared me for it. After the knock you’ve completed one “pulse”….my prescription is for 4 pulses twice daily. I can also do 9 pulses as a rescue if needed. I have not felt ANYTHING unusual when using the device – no dizziness or pain or anything like that.

    eNura has a nurse contact you regularly by phone or email to discuss how your treatments are going. I spoke to my nurse for the first time today. She was careful in what she said due to HIPPA rules, however, she said 30% of her patients (she has 100 like me) receive some reimbursement from their insurance companies. Also, patients that DO experience results notice improvement in 7-10 weeks.

    That’s about it for now. I will continue the treatments and post updates….we’ll see where it goes.

  • Fred
    4 years ago

    Thanks for the nice welcome Meaghan.

  • Meaghan Coneys moderator
    4 years ago

    Hi Fred,

    Thank you for your comment! Sounds like you have had a difficult 3 years with migraines occurring frequently, so even though there was the large expense associated with the device, it seems worth it. It is great to hear your experience as you mentioned you haven’t posted in the past. We, at Migraine.com, would love to hear more from you and look forward to reading about your progress. Please keep us posted! Wishing you all the best.

    Warmly,

    Meaghan (Migraine.com Team)

  • Bulldog
    4 years ago

    Any update on the effectiveness and availability of the device?

  • bluebird
    5 years ago

    Thanks Kerrie- I have just been sent a RX for this device from the Mayo. I have to rent it and it is pricey but I am at the end of most protocols. Any news since last year about ongoing studies or individual stories about it’s effectiveness? Any more news about risk? Any more clarity about what type of migraine might benefit? I have “brain stem with aura intractable”. Thank you so much for your continued support and sharing.

  • stellajanie
    5 years ago

    Kerrie, Does it stop the actual aura, though!? The article did not specify.

  • ouch...}:/
    5 years ago

    I was able to try this device one in my doctors office. It was pretty impressive but I needed help. I’ve had 3 stroke & holding up the device behind me head was difficult & pushing the buttons on both sides at the same time “up & foward” was hard with decreased feeling in my hands. The idea is great. The use is still in the making for those who have other invisible disabilities just like our migraines.

  • Jennifer Sommers Roy
    5 years ago

    Where can you join test studies? I’ve had a migraine for 15 plus months. Pain level as low as 3 as high as 12. Something has to give.

  • Mindy
    5 years ago

    This device uses magnetic forces, and the Cefaly uses transdermal nerve stimulation. Kerrie, have you gotten to try the Cefaly device yet?

  • Tineke
    5 years ago

    Can anybody tell me the difference between this defice and the Cefaly??

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