Evaluation of a Novel Device for Treatment of Migraine Headache
Public ClinicalTrials.gov record NCT03361423. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double Blinded, Sham Controlled Clinical Study to Evaluate the Safety and Efficacy of the Nerivio Migra 1, a Neuromodulation Device, for the Acute Treatment of Migraine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. It is tolerable by patients and associated with no adverse effects. The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere. This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications. The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra electro stimulation device for the reduction of migraine headache during an attack of migraine with or without aura. The study is intended for subject with 2-8 migraine episodes per month. patients will receive the device, either an active or a placebo type, and will be asked to use the device at home or in any location that they will be when the migraine starts. The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral nervous system at onset of a migraine attack significantly reduce headache pain demonstrated by a significant difference between proportions of responders to the active treatment stimulation in comparison to proportion of responders that will use a placebo device.
Study identification
- NCT ID
- NCT03361423
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 296 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 16, 2017
- Primary completion
- Nov 24, 2018
- Completion
- Dec 24, 2018
- Last update posted
- May 18, 2021
2017 – 2018
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hartford Headache Center | Hartford | Connecticut | 06107 | — |
| Clinvest Research | Springfield | Missouri | 65810 | — |
| Mercy Hospital | St Louis | Missouri | 63141 | — |
| Clinical Reseach Consortium | Las Vegas | Nevada | 89119 | — |
| Northwell Health, Inc | New York | New York | 11042 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03361423, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 18, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03361423 live on ClinicalTrials.gov.