There’s been significant curiosity generated in the online Migraine community recently by a video showing a small “ear piece” that may be able to prevent Migraine attacks. When investigating, I found that there has been a small study of a vestibular stimulator for Migraine prevention. The device is not, however, as shown in the video. The video uses what appears to be a small Bluetooth device that fits into one ear. The device that is actually being tested is similar to dual over-the-ear headphones attached to a controller by wires.
“To evaluate the safety and efficacy of a novel solid-state, caloric (temperature change) vestibular stimulation (CVS) device to provide adjuvant therapy (used in combination with another therapy) for the prevention of episodic Migraine in adult Migraineurs.”
- This was a multicenter, parallel-arm, block-randomized, placebo-controlled clinical trial (clinicaltrials.gov: NCT01899040).
- Study participant completed a three-month treatment trial with the TNMTM device developed by Scion NeuroStim for caloric (temperature change) vestibular stimulation (CVS).
- The primary endpoint was the change in monthly Migraine days from baseline to the third treatment month.
- Secondary endpoints were:
- 50 percent responder rates
- change in prescription analgesic usage
- difference in total subjective Migraine related pain scores
- Device safety assessments included evaluation of any impact on mood, cognition, or balance
- Study participants administered two treatments per day, separated by at least one hour, with the device for three months.
- There were 50 participants in the active device group and 30 in the placebo group.
- Active-arm participants showed immediate and continued steady declines in migraine frequency over the treatment period.
- After 3 months of treatment:
- Participants in the active device arm of the study reported 3.9 fewer Migraine days per month.
- Participants in the placebo arm of the study reported 0.6 fewer Migraine days per month.
- Active arm subjects also reported greater reductions in acute medication usage and monthly pain scores compared to participants in the placebo arm.
- No adverse effects on mood, cognition, or balance were reported.
- Subjects completed the trial with an average rate of 90 percent treatment adherence.
“The TNMTM device for CVS appears to provide a clinically efficacious and highly tolerable adjuvant therapy for the prevention of episodic migraine.”
Comments and implications for patients:
This was definitely an interesting study, and it’s always good to see research into treatments that have a lower potential side effects profile than so many oral medications have. We need to remember, however, that this was a very small study. More and larger studies need to be conducted, both to validate this study and to gather data that would be necessary for submitting the device to the FDA for approval. Thus, it would be approximately five years before we could expect to see this device on the market.
Wilkinson D, Kristen K, Rogers L, et. al. Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial. Headache. Early View. First published online June 27, 2017.
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