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

NCT04194008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2021-02-02

Study results available
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Summary

A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases:

Phase I - Run-in:

Eligible participants will be trained to use a smartphone migraine diary application. During the 4 weeks of this phase, participants will be instructed to report all their migraines and headaches at onset, 2 hours and 24 hours post report .

Phase II - Treatment:

A 4-week treatment phase in which participants will be asked to treat their migraine headaches with the Nerivio device and report it using the smartphone application at baseline, 2 hours and 24 hours post-treatment.

Phase III - Follow-up:

An 8-week follow-up phase in which participants will incorporate the Nerivio device into their usual care according to their preference (Nerivio only, medication only, both or none). Participants will be asked to report all their migraines or headaches at onset, 2 hours post report and 24 hours post report.

Conditions

  • Chronic Migraine

Interventions

DEVICE

Nerivio

A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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

  • Brian Grosberg, MD · Hartford Healthcare Center

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
2019-11-18
Primary Completion
2020-05-22
Completion
2020-08-30
FDA Device
Yes

Countries

  • United States

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 NCT04194008 on ClinicalTrials.gov