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The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

NCT03631550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2022-09-22

Study results available
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Summary

this study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relivion®)

Conditions

  • Acute Migraine

Interventions

DEVICE

Relivion active

1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation

DEVICE

Relivion Sham

1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation

Sponsors & Collaborators

  • Neurolief Ltd.

    lead INDUSTRY

Principal Investigators

  • stewart J. Tepper, Dr. · Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-29
Primary Completion
2020-08-04
Completion
2020-08-04
FDA Device
Yes

Countries

  • United States
  • 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 NCT03631550 on ClinicalTrials.gov