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Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines

NCT03716505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2020-09-11

No results posted yet for this study

Summary

The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.

Conditions

  • Migraine Disorders

Interventions

DEVICE

gammaCore Sapphire active

GammaCore Sapphire™ is a handheld, non-invasive, low voltage electrical device which stimulates the vagus nerve by producing weak 120 second electrical stimulation cycles that may help reduce, ease, lessen or stop your migraine symptoms. GammaCore Sapphire™ has been approved for the treatment of headache, including migraine by the United States Food and Drug Administration (FDA).

DEVICE

gammaCore Sapphire Sham

The sham device is a hand-held portable device that appears identical to gammaCore Sapphire, in look, weight, visual and audible feedback, user application, and control. Like gammaCore Sapphire, the sham device is a multi-use device.

Sponsors & Collaborators

  • ElectroCore INC

    lead INDUSTRY

Principal Investigators

  • Peter Staats, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-11-02
Primary Completion
2020-09-09
Completion
2020-09-09
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 NCT03716505 on ClinicalTrials.gov