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Remote electrical neuromodulation for migraine prevention: A double‐blind, randomized, placebo‐controlled clinical trial.

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Title: Remote electrical neuromodulation for migraine prevention: A double‐blind, randomized, placebo‐controlled clinical trial.
Authors: Tepper, Stewart J., Rabany, Liron, Cowan, Robert P., Smith, Timothy R., Grosberg, Brian M., Torphy, Bradley D., Harris, Dagan, Vizel, Maya, Ironi, Alon, Stark‐Inbar, Alit, Blumenfeld, Andrew M.
Source: Headache: The Journal of Head & Face Pain. Mar2023, Vol. 63 Issue 3, p377-389. 13p.
Subjects: Migraine prevention, Research, Confidence intervals, Migraine, Treatment effectiveness, Randomized controlled trials, Blind experiment, Descriptive statistics, Research funding, Headache, Transcutaneous electrical nerve stimulation, Longitudinal method, Evaluation
Abstract: Objective: To assess the clinical efficacy of remote electrical neuromodulation (REN), used every other day, for the prevention of migraine. Background: Preventive treatment is key to managing migraine, but it is often underutilized. REN, a non‐pharmacological acute treatment for migraine, was evaluated as a method of migraine prevention in patients with episodic and chronic migraine. Methods: We conducted a prospective, randomized, double‐blind, placebo‐controlled, multi‐center trial, with 1:1 ratio. The study consisted of a 4‐week baseline observation phase, and an 8‐week double‐blind intervention phase in which participants used either REN or a placebo stimulation every other day. Throughout the study, participants reported their symptoms daily, via an electronic diary. Results: Two hundred forty‐eight participants were randomized (128 active, 120 placebo), of which 179 qualified for the modified intention‐to‐treat (mITT) analysis (95 active; 84 placebo). REN was superior to placebo in the primary endpoint, change in mean number of migraine days per month from baseline, with mean reduction of 4.0 ± SD of 4.0 days (1.3 ± 4.0 in placebo, therapeutic gain = 2.7 [confidence interval −3.9 to −1.5], p < 0.001). The significance was maintained when analyzing the episodic (−3.2 ± 3.4 vs. −1.0 ± 3.6, p = 0.003) and chronic (−4.7 ± 4.4 vs. −1.6 ± 4.4, p = 0.001) migraine subgroups separately. REN was also superior to placebo in reduction of moderate/severe headache days (3.8 ± 3.9 vs. 2.2 ± 3.6, p = 0.005), reduction of headache days of all severities (4.5 ± 4.1 vs. 1.8 ± 4.6, p < 0.001), percentage of patients achieving 50% reduction in moderate/severe headache days (51.6% [49/95] vs. 35.7% [30/84], p = 0.033), and reduction in days of acute medication intake (3.5 ± 4.1 vs. 1.4 ± 4.3, p = 0.001). Similar results were obtained in the ITT analysis. No serious device‐related adverse events were reported in any group. Conclusion: Applied every other day, REN is effective and safe for the prevention of migraine. [ABSTRACT FROM AUTHOR]
Copyright of Headache: The Journal of Head & Face Pain is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Remote electrical neuromodulation for migraine prevention: A double‐blind, randomized, placebo‐controlled clinical trial.
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– Name: Abstract
  Label: Abstract
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  Data: Objective: To assess the clinical efficacy of remote electrical neuromodulation (REN), used every other day, for the prevention of migraine. Background: Preventive treatment is key to managing migraine, but it is often underutilized. REN, a non‐pharmacological acute treatment for migraine, was evaluated as a method of migraine prevention in patients with episodic and chronic migraine. Methods: We conducted a prospective, randomized, double‐blind, placebo‐controlled, multi‐center trial, with 1:1 ratio. The study consisted of a 4‐week baseline observation phase, and an 8‐week double‐blind intervention phase in which participants used either REN or a placebo stimulation every other day. Throughout the study, participants reported their symptoms daily, via an electronic diary. Results: Two hundred forty‐eight participants were randomized (128 active, 120 placebo), of which 179 qualified for the modified intention‐to‐treat (mITT) analysis (95 active; 84 placebo). REN was superior to placebo in the primary endpoint, change in mean number of migraine days per month from baseline, with mean reduction of 4.0 &#177; SD of 4.0 days (1.3 &#177; 4.0 in placebo, therapeutic gain = 2.7 [confidence interval −3.9 to −1.5], p &lt; 0.001). The significance was maintained when analyzing the episodic (−3.2 &#177; 3.4 vs. −1.0 &#177; 3.6, p = 0.003) and chronic (−4.7 &#177; 4.4 vs. −1.6 &#177; 4.4, p = 0.001) migraine subgroups separately. REN was also superior to placebo in reduction of moderate/severe headache days (3.8 &#177; 3.9 vs. 2.2 &#177; 3.6, p = 0.005), reduction of headache days of all severities (4.5 &#177; 4.1 vs. 1.8 &#177; 4.6, p &lt; 0.001), percentage of patients achieving 50% reduction in moderate/severe headache days (51.6% [49/95] vs. 35.7% [30/84], p = 0.033), and reduction in days of acute medication intake (3.5 &#177; 4.1 vs. 1.4 &#177; 4.3, p = 0.001). Similar results were obtained in the ITT analysis. No serious device‐related adverse events were reported in any group. Conclusion: Applied every other day, REN is effective and safe for the prevention of migraine. [ABSTRACT FROM AUTHOR]
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  Data: &lt;i&gt;Copyright of Headache: The Journal of Head &amp; Face Pain is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=162595237
RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1111/head.14469
    Languages:
      – Code: eng
        Text: English
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        PageCount: 13
        StartPage: 377
    Subjects:
      – SubjectFull: Migraine prevention
        Type: general
      – SubjectFull: Research
        Type: general
      – SubjectFull: Confidence intervals
        Type: general
      – SubjectFull: Migraine
        Type: general
      – SubjectFull: Treatment effectiveness
        Type: general
      – SubjectFull: Randomized controlled trials
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      – SubjectFull: Blind experiment
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      – SubjectFull: Descriptive statistics
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      – SubjectFull: Research funding
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      – SubjectFull: Headache
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      – SubjectFull: Transcutaneous electrical nerve stimulation
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      – SubjectFull: Longitudinal method
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      – SubjectFull: Evaluation
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              Text: Mar2023
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