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Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine

NCT04161807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-02-16

Study results available
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Summary

This study is intended to evaluate the efficacy and safety of Nerivio, an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine, for the acute treatment of migraine in people with chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The study duration consists of a 4 weeks of active treatment with the device in about 40 patients.

Conditions

  • Chronic Migraine

Interventions

DEVICE

Nerivio

The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.

Sponsors & Collaborators

  • Theranica

    lead INDUSTRY

Principal Investigators

  • Paul Wright · Nuvance Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2020-02-18
Completion
2020-02-18
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 NCT04161807 on ClinicalTrials.gov