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The goal of this clinical trial is to determine the efficacy of a new, improved neuromodulation device that can be worn on the forehead or back of the neck to relieve migraine pain. To measure efficacy, investigators will compare how measured outcomes resulting from active stimulation with this device compare to those of sham treatment.
Full description
The objective of this study is to examine the extent to which a transcutaneous electrical nerve stimulation (TENS) device safely helps participants with acute migraines reduce migraine pain intensity, achieve pain freedom, and experience sustained pain freedom. The TENS device attaches to a gel pad that can be worn in one of three placement locations (on the center of the forehead, side of the forehead, or at the suboccipital region on the back of the neck) to stimulate sensory nerves implicated in migraine pain. The TENS device outputs two active electrical waveforms that differ in stimulation intensity but can both be used to address migraine pain through a 1-hour treatment session. To achieve the study objective, investigators will perform a randomized controlled trial (RCT) with a 3x3 factorial design in which participants will be randomized across the 3 TENS device placement options and each participant will test 3 waveforms: two active waveforms and a sham waveform. Each waveform will be used in a distinct migraine episode. The investigators will evaluate the study aims for each active treatment (six in total) compared to its corresponding sham.
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Inclusion criteria
Diagnosis of migraine with or without aura, identified via participant-provided medical records.
Average migraine pain is 4 or more on the 0-10 Numerical Rating Scale (NRS) for pain.
Passes ID-Migraine pre-screening questions and has ID-Migraine score ≥ 2:
a. ID-Migraine pre-screening questions: i. How many headaches have participants experienced within the previous 3 months?
Needs to be ≥ 6 headaches ii. Do the headaches that participants experience limit the ability to work, study, or enjoy life, or does the participant wish to speak with a healthcare professional about the headaches? (yes / no)
Participant needs to respond "yes" b. ID-Migraine questions: i. Over the last 3 months, did participants have any of the following with headaches?
Felt nauseated or sick to stomach (yes [1] / no [0])
Light bothered them (a lot more than when headaches are not present)? (yes [1] / no [0])
Headaches limited the ability to work, study, or do what needed to be done? (yes [1] / no [0])
Able to understand and provide informed consent.
Age 18 and older.
US resident.
Has experienced migraines for at least 1 year prior to recruitment.
Onset of migraines occurred at age 50 years or younger.
Average of at least 2 migraines per month of moderate to severe intensity.
Is either on a) no medications or b) a stable dose of migraine-preventative medication for at least 2 months prior to recruitment.
Willing to refrain from altering preventive medication for migraines (or from using botox), commit to using Enso as the first-line treatment, and wait at least 2 hours after Enso treatment before using any additional abortives during the study period.
Participants must own an iPhone with iOS 15 or newer, or an Android phone with Android 9 or newer, with Bluetooth capability and access to either the Apple App Store (for iOS devices) or Google Play Store (for Android devices).
Has an email account.
Exclusion criteria
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180 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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