Cephalalgia Reports · Published 2025-09-01 · DOI 10.1177/25158163251377996
Objective This study aims to demonstrate a real-world preventive response to the external combined occipital and trigeminal neurostimulation (eCOT-NS) device at baseline and at 3-month follow-up in patients treated for headache. Methods By using a prospective, observational, longitudinal approach for this study, we assessed the preventive treatment of headache in patients from a subspeciality clinic over 3 months. Participants with any headache disorder managed by the Lewis Headache Center who were prescribed eCOT-NS as part of standard of care were enrolled from July 2022 to June 2024. While using the eCOT-NS device, participants were assessed at baseline and at 3-month follow-up for moderate to severe headache days (MMD). Secondary measures included monthly headache days (MHD), average headache severity and Migraine Disability Assessment (MIDAS). Responder rate (in terms of reduction in MMD), subjective response, and adverse events were also reported. Results Seventeen participants completed the trial with mean age 50.9 years (range, 27–71 years) and 88% (15/17) female. At baseline, 94% (16/17) of participants had chronic migraine, and one participant (6%) had isolated occipital neuralgia. There was no statistically significant decrease (95% confidence interval) in MMD ( P = .071) from a baseline median of 11.7 (3rd and 1st quartiles: 10, 28.3) to 6 (3rd and 1st quartiles: 3, 5) days at 3-month follow-up. Increased adherence was not associated with MMD, but was associated with more improved MHD (median β: 3.25, 95% CI: 0.689, 6.707). Of the secondary outcomes, only MHD were significantly reduced from a median of 30 (3rd and 1st quartiles: 27, 30) to 23 (3rd and 1st quartiles: 15, 23) [ P -value .002]. The other outcomes did not show significant changes from baseline ( P -values for Severity: 0.124, MIDAS: 0.277). Of the 17 participants, 47% (8/17) were ≥30% responders, 41% (7/17) were ≥50% responders, 23% (4/17) were ≥75% responders, and 11% (2/17) were 100% responders. Subjectively, 29% of participants (5/17) reported no benefit, 11% (2/17) reported inconsistent benefit, 41% (7/17) reported partial benefit, and 17% (3/17) reported complete benefit. No severe adverse outcomes occurred, but 23% of participants (4/17) reported worsening headache. Conclusion Use of the eCOT-NS device as a preventive treatment may reduce MHD, but larger confirmatory studies are needed. Therefore, if a patient can afford it, the eCOT-NS device could be tried preventively in patients with chronic migraine given its low side effect profile. Trial Registration None
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