N/A
N=42
Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine
Chronic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT04161807 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Proportion of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment — 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nerivio (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Theranica
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment |
19 | — |
| SECONDARY Proportion of Participants With Pain Disappearance at 2 Hours Post Treatment |
10 | — |
| SECONDARY Proportion of Participants With Disappearance of Nausea and/or Vomiting at 2 Hours Post-treatment |
10 | — |
| SECONDARY Proportion of Participants With Disappearance of Photophobia at 2 Hours Post-treatment |
9 | — |
| SECONDARY Proportion of Participants With Disappearance of Phonophobia at 2 Hours Post-treatment |
8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants aged 18-75 years old.
- Participants meeting the ICHD-3 diagnostic criteria for chronic migraine
- Participants have personal access to a smartphone
- Participants must be able and willing to comply with the protocol
- Participants must be able and willing to provide written informed consent
Exclusion Criteria
- Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
- Participants with uncontrolled epilepsy.
- Lack of efficacy, after an adequate therapeutic trial, of at least two migraine specific acute medications
- Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study
- Pregnant, trying to get pregnant or breastfeeding female participants
- Subjects participating in any other interventional clinical study.
- Participants without basic cognitive and motor skills needed to operate a smartphone
- Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
- Participants who have previous experience with the device
Data sourced from ClinicalTrials.gov (NCT04161807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.