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Migraine With and Without Aura Characteristics and Response to Remote Electrical Neuromodulation (REN) Treatment

NCT06023953 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31715

Last updated 2025-08-15

No results posted yet for this study

Summary

This is a Post-marketing, real-world evidence study investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine patients with and without aura, as well as characterizing demographic and attack characteristic differences between migraine patients with and without aura.

Safety will be assessed by the number and type of device-related adverse events. Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment. Disease characteristics will look into demographic and attack differences between patients with and without aura.

Conditions

  • Migraine With Aura
  • Migraine Without Aura

Interventions

DEVICE

Nerivio device

REN treatment with Nerivio device

Sponsors & Collaborators

  • Theranica

    lead INDUSTRY

Principal Investigators

  • Alit Stark Inbar, PhD · Theranica Bio-Electronics Ltd

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-09-30
Completion
2024-12-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06023953 on ClinicalTrials.gov