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DARIEN, Conn., Nov. 27, 2024 /PRNewswire/ -- For the first time, researchers have examined the safety and efficacy of migraine neuromodulation therapy across subtypes of migraine-associated most bothersome symptoms (MBS). 

These researchers conducted a post hoc analysis of the TEAM (Trial of eTNS for the Acute Treatment of Migraine) study, which is the largest clinical trial to date that examines the effectiveness of external trigeminal nerve stimulation (eTNS) for the acute treatment of migraine. The original TEAM study demonstrated that 2-hour treatment of migraine with eTNS resulted in higher rates of pain freedom and resolved MBS when compared to sham stimulation.

While the TEAM study demonstrated that eTNS effectively treats the most bothersome migraine symptom (MBS), the effectiveness of eTNS by specific type of MBS had not been examined. Therefore, the investigators performed the first analysis examining the effectiveness of eTNS for each type of MBS.

"A post hoc analysis of migraine-associated symptoms from the TEAM (a phase 3 randomized, double-blind, sham-controlled Trial of eTNS for the Acute Treatment of Migraine) study," published in Headache: The Journal of Head and Face Pain, found that external trigeminal nerve stimulation produced consistent benefits in patients with certain MBS subtypes. 

Specifically, patients who experienced MBS of photophobia (light sensitivity), phonophobia (sound sensitivity), and vomiting and used 2-hour eTNS therapy for acute migraine treatment experienced consistent benefits in pain freedom at 2 hours post-treatment, pain relief at 24 hours post-treatment, relief of migraine severity, and resolution of MBS and all migraine-associated symptoms, compared to sham stimulation.

For patients with nausea as their MBS, 2-hour eTNS treatment provided more variable response for pain relief at 2 and 24 hours post treatment. However, this same group experienced consistent pain relief at 24 hours post treatment, resolution of nausea, and other migraine associated symptoms following 2-hour eTNS treatment compared to sham stimulation.

"Essentially, the question we sought to answer with this paper was, 'Is the response to trigeminal nerve stimulation different according to different subtypes of most bothersome symptom?" said Michael A. L. Johnson, MD, one of the co-investigators.

The paper's findings suggest that patients with nausea MBS may experience more difficulty in achieving migraine relief compared to other MBS subtypes, which is consistent with prior literature regarding other acute migraine therapies. "As a result," Dr. Johnson said, "patients with nausea MBS may require a more strategic and stratified approach to acute migraine treatment compared to other MBS subtypes." The refractory nature of migraine treatment for patients who experience nausea MBS is not unique to eTNS or neuromodulation. 

Migraine is a complex and debilitating neurological disorder that affects more than 1 billion people worldwide. Despite migraine's prevalence, the condition is often misunderstood, underdiagnosed, and ineffectively treated. Treatment protocols often focus primarily on relieving headache pain, not MBS. Also, MBS tend to be less acknowledged and discussed, compared to migraine pain, even though MBS can be equally or more debilitating than migraine pain.  

The cross‐sectional, observational Migraine in America Symptoms and Treatment (MAST) study found that most people with migraine reported all three symptoms of nausea, photophobia, and phonophobia. (Vomiting was not named as a separate MBS). The most common MBS was photophobia, reported by 49.1% of respondents. Among women, nausea was the most common MBS (79.8% of respondents).

The U.S. Food and Drug Administration recommends that most bothersome migraine-associated symptom be included as a primary efficacy endpoint in clinical trials that assess acute treatments for migraine, because it is such an important target symptom for treatment.

Further studies are needed to elucidate the underlying pathophysiological differences between MBS subtypes and help clinicians understand the best treatment approaches, particularly for patients with nausea as their MBS. Past studies have demonstrated that patients with nausea MBS demonstrate more recalcitrance when treated with acute medications. 

Why is this difference present, and what impact does it have (medically and financially) on patients with nausea MBS? More research is needed to address these questions.

"MBS are very understudied," noted Deena Kuruvilla, MD, the principal investigator of the study. "Clinicians tend to focus on treating headache pain, while MBS can be much more disabling for people with migraine. This study confirms that we, as clinicians, should be treating migraine as the complex, multi-symptom brain disorder that it is." 

The post hoc analysis and the original TEAM study were funded by CEFALY Technology. 

"We already know that CEFALY's eTNS migraine treatment device has been shown to be an effective and safe option in resolving MBS in addition to resolving migraine pain," said CEFALY Technology CEO Jen Trainor McDermott. "From this analysis, we now know that migraine patients with nausea may also require additional treatments, such as antiemetics or even anti-nausea neuromodulatory devices, in addition to eTNS therapy."

About CEFALY Technology:

CEFALY Technology is the maker of CEFALY, an FDA-cleared, over-the-counter wearable medical device clinically proven to help reduce migraine frequency and relieve migraine pain. CEFALY Technology is a Belgium-based company with its U.S. offices based in Darien, Conn., specializing in electronics for medical applications. CEFALY Technology's mission is to provide innovative, ever-evolving technology that enables people with migraine to take control of their treatment and live happier, healthier lives.

Media Contact:
CEFALY
Jen Trainor McDermott
CEO
j.trainor@cefaly.com

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SOURCE CEFALY Technology