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Your Guide to Getting a Spring TMS

getting-a-spring-tmsA non-drug treatment with few reported side effects that works as both an acute treatment for migraine attacks and a migraine preventive. That describes the Spring TMS, which received FDA approval in 2014 and is slowly becoming available throughout the country. Compared to other technologies, Spring TMS’s rollout has lacked much fanfare, but it’s a pretty exciting treatment with a long history of research to support its use.

Transcranial magnetic stimulation (that’s what TMS stands for) uses a very short magnetic field to send a brief energy pulse through the skull into brain tissue. The pulse causes very mild electrical currents in the brain that are believed to stop a migraine attack by interrupting the abnormal electrical activity in the brain caused by migraine.

My experience with Spring TMS might make you wary. I believe the worsening of my migraine attacks while using it was coincidental, not caused by the device itself. I still advocate for trying it because the research on Spring TMS is quite strong. I also advocate for talking to your doctor about what to do if your head pain worsens while using the device.

Here’s what you need to know for getting a Spring TMS, from which doctors can prescribe it and learning how to use it to its cost and how the rental program works. It contains an exact transcript of the questions an eNeura executive answered for me in April.

Kerrie: Can any doctor prescribe Spring TMS? If not, how can a patient choose a doctor to prescribe it?

eNeura: The device is currently available by prescription in specialist headache centers around the US. If you want to see which doctors near you can prescribe the Spring TMS email customercare@eNeura.com or call 1(408) 245-6400, and press 1 to speak with a Customer Care representative. Doctors who are interested in prescribing the device can also email or call eNeura customer care.

How much does it cost?

Spring TMS is available by prescription under a rental program. The cost is comparable to other prescribed migraine treatments. The company offers a $300 discount off the first 3 months for new patients. A new 3 month prescription is $450 ($150 per month) plus a one time $50 shipping charge. Total charges for the first three-month period come to $500.

[The above pricing only applies for the first three months of use. Here’s updated pricing information from eNeura’s customer service department, current as of Aug. 24, 2016: We rent the device in 3-month increments.  At list price, the cost per month is $250. A patient who selects the 12-month option will average $175 per month for SpringTMS. We also offer new patients a $300 discount on their first prescription, which would bring the cost per month down from $250 to $150 for that first prescription.]

Does insurance cover SpringTMS? 

As a new migraine treatment, insurance coverage for Spring TMS varies and will likely require documentation of medical necessity from the prescribing physician. eNeura has retained an insurance reimbursement consulting service for patients wishing to pursue insurance coverage. eNeura Customer care will help you get started. Call 1(408) 245-6400, and press 1 to speak with a Customer Care representative.

Do you bill insurance? If not, have patients been successful applying for reimbursement from insurance companies?

eNeura does not bill insurance companies, but patient’s can submit invoices to their insurance company for potential reimbursement.

How does the rental program work?/How does a patient renew a prescription?

eNeura: Near the end of the three-month period, the patient’s doctor can send a renewal prescription to eNeura. eNeura, in turn, emails an invoice for the renewal period. Once that’s paid they will mail a new SIM card to replace the original SIM card in the machine. If the prescription is not renewed and the new data card is not inserted in the Spring TMS unit, it stops working. 

Is special training required to learn how to use the device?

It is easy to use and is fully automated to guide the patient through treatment in a step-by-step fashion. While there is no special training required, eNeura offers an individualized program to support you as you begin using the Spring TMS.

A Clinical Education Consultant will contact you when your Spring TMS arrives to help you get started and answer your questions. During your first 3-4 months of use, your nurse will continue to support you in your treatment plan, answer your questions, review your diary and report your progress to your doctor. 

Is the unit shipped directly to the patient or does it go through the doctor?

Prescribing doctors send the three-month prescription to eNeura. Once the prescription is received, eNeura prepares the device and ships it directly to the patient’s home.

If a patient stops using the device, how do they return it?

When a patient receives their SpringTMS in the mail they are instructed to keep the original packaging. If a patient stops using the device, it needs to be shipped back to eNeura. Contact eNeura Customer Care to obtain a prepaid return shipping label. There is no charge for returning the device.

What else would you like patients to know about SpringTMS?

Many migraine patients are looking for non-drug treatment options. For them medications either don’t work… may be contraindicated or just not well tolerated. SpringTMS offers a safe clinically proven treatment option without medication side effects.

Longtime reader Timothy Bauer checked in with eNeura on July 20 after reading my article on Migraine.com. He was told that doctors who have not already been trained in prescribing the device may have to wait several months for training. The company gave him the names of doctors in his area who have already been trained.

 

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Spring TMS: A Patient’s Experience

Spring TMS device imageOf all the new treatment roller coasters I’ve been on, the Spring TMS brought the most emotional ups and downs. I anticipated its release for 10 years, which means I’d stored up a decade of expectation. Nothing but a complete cessation of my migraine attacks could have lived up to that much hype. Here’s how the trial went for me:

Week 1

I still had constant head pain, but little fatigue and not much cognitive dysfunction. The reduction in fatigue and cognitive dysfunction brought enormous improvement to my quality of life. The pain was a 5 or 6, which is worse than my baseline pain level. It felt more like a headache than a migraine attack, though the pain was far more migraine-like than usual. It was centered around my left eye and temple (instead of an all-over throbbing pain). A couple ibuprofen took the edge off when the pain began to interfere with my ability to function.

Week 2

The migraine pain from the previous week was lower, but still present. I was fully functional with little fatigue or cognitive dysfunction, so I had no complaints. I celebrated by emptying the shed and reorganizing the entire house.

Week 3

I was still doing better than before I started using the Spring TMS, but my fatigue increased as the week wore on. Then I started getting slow-build migraine attacks (that’s my term, nothing technical, but I’m pretty sure the meaning is obvious). They seemed totally random, with no identifiable triggers. Then food that’s normally OK started being a trigger. Then the act of eating itself became a trigger (even with DAO). All the while, the fatigue kept increasing.

In this week, I noticed that I’d use the device and the migraine attack would let up, but return a few hours later. The length of this reprieve reduced steadily until I’d feel worse immediately upon using the Spring TMS. It’s like the device caused an instant rebound headache.

After spending two days laid up with moderate pain and major fatigue and cognitive dysfunction, I decided to stop the treatment.

Week 4

After I stopped using the Spring TMS, the fatigue slowly decreased as the week progressed, though some cognitive dysfunction remained. I wasn’t worried. It took a week to get over the initial side effects, so I figured it would take a week to return to baseline. I still thought I’d be able to use the device again when things settled down.

When a migraine attack struck an hour before an appointment and wasn’t responding to triptans. I gave the Spring TMS a try. I felt worse instantly and spend the rest of the day in bed.

Week 5

I was still spending more time laid up than before I started using the Spring TMS. I tried to keep the worry at bay, but the thoughts keep creeping up: “What if this is my new normal? What if I never go back to how well I was doing before I started the treatment?”

I kept reminding myself of an escapade with dizziness last February. My doctor said that a four-day migraine attack temporarily changed my brain, which made me more sensitive to the side effects of bupropion (Wellbutrin, a drug that has always made me dizzy unless I’m very careful with it). My brain didn’t normalize after that for two weeks. I used the Spring TMS for three weeks and my brain clearly reacted to it. I told myself that maybe it would take three weeks for my brain to settle down. Or three months. Either way, I told myself that there was no reason to think I’d feel this way forever.

Beyond

It has been many months since I stopped using the Spring TMS. Eating and drinking anything but water continues to be a migraine trigger. My overall pain levels returned to baseline, but I spend more time at higher levels of pain than before I tried the device. My fatigue and cognitive dysfunction did not improve beyond the fifth week (though the ketogenic diet has improved my cognitive dysfunction.)

I suspect it’s a coincidence that I became more reactive to food (and eating) while using the device, though determining cause and effect is impossible. My doctor said he’s had patients become worse while using the device, but I’m the only one who has had a permanent change. A friend also tried it and got worse, but she returned to baseline within a week of stopping it.

Parting Wisdom

Perhaps surprisingly, I would still encourage people to try the Spring TMS. Just be aware that your migraine attacks could worsen. Before you try it, talk with your doctor about that possibility and find out what they recommend—tough it out and hope the attacks will improve or stop altogether? Based on my discussion with my doctor, I would do the latter, but only you and your doctor can determine the right approach for you.

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Transcranial Magnetic Stimulation for Migraine: Spring TMS Study

SpringTMSAre you eager to get your hands on a transcranial magnetic stimulator to treat migraine? The Spring TMS, which received FDA approval last May, won’t be available to patients until the completion of a post-approval study to determine how to use the Spring TMS most effectively. And the study can’t be completed until more participants are recruited. You can try the Spring TMS for free and help bring it closer to availability to others by participating in the study.

The study is being conducted at six locations throughout the United States, but the exact locations are not listed on ClinicalTrials.gov. If you’re able to travel, it might be possible to participate even if you don’t live in one of those locations. If you’re interested in participating, take a look at eNeura SpringTMS Post-Market Observational US Study of Migraine (ESPOUSE) for details and criteria for participation. If you’re still interested, contact Cynthia Harris at (775) 392-2970 or cindy@clinregconsult.com with your questions and to get location details.

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More Migraine and Headache Hope: 2014 American Headache Society Symposium

Energizing and encouraging are the words I’d use to describe the American Headache Society’s symposium last week/weekend. The opening remarks on Thursday morning actually made me cry. After the AHS president, Dr. Lawrence Newman, shared his heartfelt frustrations with migraine treatment and gave an impassioned plea for the 36 Million Migraine campaign, the room went dark. Dr. Newman then asked everyone to stand up with their cell phones lit to “shine a light on migraine_and_headache_hopemigraine.” This picture from the AHS Twitter feed shows a small portion of the room in this powerful moment.

The strength of the moment was reinforced when the first presenter of the day, Dr. Dawn Buse, asked everyone in the audience with migraine to stand. Three-quarters of the room stood. She then asked everyone who had a loved one with migraine to stand. I don’t believe anyone in the room remained seated.

“These people care,” I thought so many times throughout the conference. I saw so many doctors, physician assistants, nurse practitioners, nurses and psychologists who are passionate and enthusiastic about headache medicine. They are frustrated about lack of funding and the stigma of headache and migraine, but they care deeply about and are dedicated to their patients. They are excited – ahem, cautiously optimistic – about the CGRP drugs that are in development for migraine as well as the neuromodulation treatments that are on the horizon (like transcranial magnetic stimulation and vagal nerve stimulation, both of which are noninvasive and should be available to patients soon).

This is the third year I’ve attended this particular conference and the fourth headache conference I’ve been to. The energy felt different. Maybe it was because I felt better and was able to engage more, but the enthusiasm and optimism seemed stronger than I’ve noticed before. Even more encouraging was the number of people new to headache medicine, mostly fellows in their early days of specialization, who attended the conference.

Yes, research for migraine and all headache disorders is underfunded. Yes, the arsenal of treatments is still nebulous and it’s hard to pin down what might help any individual patient. Yes, the stigma is still enormous. Yes, there is still a small portion of patients for whom it is difficult to find the right treatment. But the field is making progress and it’s being led by enthused and engaged providers who truly care for patients. The number of academic headache centers is on the rise, as is the number of fellows being trained in headache medicine each year.

I was already full of hope about the future of migraine treatment. This conference reinforced that my migraine and headache hope is well-placed. The tide is turning. It’s one of the many things I’m giving thanks for this week.

Want even more hope? Watch this interview with headache specialist and researcher Peter Goadsby. It’s well worth your eight minutes. (Many thanks to  Timothy for sending me this.)

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SpringTMS Transcranial Magnetic Stimulation for Migraine Gets FDA Approval

SpringTMS, the first transcranial magnetic stimulation device for migraine that will be available to patients, has received FDA approval. Details are still sparse, but I’ve written up what I can find in SpringTMS Transcranial Magnetic Stimulation Device for Migraine Receives FDA Approval on Migraine.com. The highlights:

  • Approval was based on a study of people with episodic migraine with aura. Participants had to have a visual, sensory or motor aura preceding at least 30% of their attacks and have between one and eight attacks a month. This may not be the final target population, though, depending on who is included in the pilot study and what the findings are.
  • Before becoming available to the general public, several headache centers in the U.S. will conduct a pilot study to determine the optimal way to use the device. These clinics have yet to be made public. I’m looking into how to become part of the study and will let you know what I find.
  • The cost is unknown. In England, it cost £160 per month (about $270 USD), as of January 2014.
  • It will probably eventually be covered by insurance, but those details are unknown.
  • It will be prescription-only.
  • SpringTMS is a smaller version of Cerena, which received FDA approval in December 2013. Cerena will not be available to patients.

Here’s what I learned about the pilot study after I saw my headache specialist, who is organizing the study, in January: Update on Transcranial Magnetic Stimulation Device Availability. It looks like it could be on track for general availability in January 2015.