One-Year Consistent Safety, Utilization, and Efficacy Assessment of Remote Electrical Neuromodulation (REN) for Migraine Treatment.
Efficacy
Long-term
Migraine
Non-pharmacological
Prospective
REN
Real-world evidence
Remote electrical neuromodulation
Safety
Utilization
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
19 Oct 2023
19 Oct 2023
Historique:
received:
13
08
2023
accepted:
25
09
2023
medline:
19
10
2023
pubmed:
19
10
2023
entrez:
19
10
2023
Statut:
aheadofprint
Résumé
Migraine is a chronic neurological disorder causing severe pain and disability in more than a billion people worldwide. Ideal treatment should provide long-term efficacy with minimal side effects. Previous studies indicate that remote electrical neuromodulation (REN) is an efficacious and safe treatment option for the acute treatment of migraine in clinical practice. This study examined long-term safety, utilization, and efficacy of REN during 12 consecutive usage months. Data from patients with migraine across the USA using REN to treat their migraine attacks were electronically collected from the Nerivio Data were analyzed from 409 people living with migraine who treated with REN for 12 consecutive months, performing a total of 39,531 treatments. The incidence of device-related adverse events (dAEs) was 1.96% (8/409), including two negligible (0.49%), five mild (1.22%), one moderate (0.24%), and no severe events. All patients continued treatment with REN despite dAEs. One-year average monthly utilization was 8.05 treatments (SD 1.15). Month-to-month utilization did not change during 12 months of consecutive use [F(4.895, 1997.204) = 2.014, p = 0.075, repeated-measures ANOVA]. One-year average efficacy showed 74.1% of users reported consistent 2-h pain relief, and 26.0% reported consistent pain freedom. Month-to-month pain relief and pain freedom did not change during 12 months of consecutive use [F(11, 1069) = 0.55, p = 0.873 and F(11, 1295) = 0.69, p = 0.750 respectively; generalized linear mixed model analysis]. REN is a safe and well-tolerated acute migraine treatment, with stable efficacy and utilization over 1 year, making it an advantageous non-drug option for the long-term management of this chronic disease. NCT05760638. Migraine is a chronic disease leading to decades of significant disability, thus requiring safe, effective, and tolerable treatment for years. Remote electrical neuromodulation (REN) is a smartphone-controlled wearable device (Nerivio
Autres résumés
Type: plain-language-summary
(eng)
Migraine is a chronic disease leading to decades of significant disability, thus requiring safe, effective, and tolerable treatment for years. Remote electrical neuromodulation (REN) is a smartphone-controlled wearable device (Nerivio
Identifiants
pubmed: 37855973
doi: 10.1007/s12325-023-02697-6
pii: 10.1007/s12325-023-02697-6
doi:
Banques de données
ClinicalTrials.gov
['NCT05760638']
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2023. The Author(s).
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