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Remote Electrical Neuromodulation Device
Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine
N/A
Waitlist Available
Led By Paul Wright
Research Sponsored by Theranica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours post treatment
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Migraine
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment
Secondary study objectives
Proportion of Participants With Disappearance of Nausea and/or Vomiting at 2 Hours Post-treatment
Proportion of Participants With Disappearance of Phonophobia at 2 Hours Post-treatment
Proportion of Participants With Disappearance of Photophobia at 2 Hours Post-treatment
+1 moreOther study objectives
Proportion of Participants With Improve Functional Disability at 2 Hours Post-treatment
Proportion of Participants With Improve Functional Disability at 24 Hours Post-treatment
Within-patient Consistency - Percentage of Participants Free of Headache Pain in at Least 50% of Their Treatments
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Nerivio device treatmentExperimental Treatment1 Intervention
participant will receive the Nerivio device for treating their migraine attacks. Treatment will be perform as soon as the participant feel that the migraine attack started
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nerivio
2022
N/A
~1160
Find a Location
Who is running the clinical trial?
TheranicaLead Sponsor
19 Previous Clinical Trials
41,323 Total Patients Enrolled
9 Trials studying Migraine
13,923 Patients Enrolled for Migraine
Paul WrightPrincipal InvestigatorNuvance Health