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 firstname.lastname@example.org 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.