Clinical trial NCT04161807: Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine
Official title: Efficacy and Safety of Nerivio™, a Remote Electrical Neuromodulation Device, for Acute Treatment of Migraine in People With Chronic Migraine: an Open Label, Single Arm, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2019-11-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This open label study includes up to 2 visits. The enrollment and device training may occur in 2 separate visits.

First visit - The first visit will include screening, enrollment and training on the application and device.

Treatment phase - Participants will be instructed to use the device for the treatment of qualifying migraine headaches (see below) as soon as possible and always within 60 minutes of onset during a period of up to 4 weeks. Participants will be instructed to use the device with the intensity level identified during the device training visit (and adjust as necessary) and make sure the stimulation is perceptible but not painful. Participants will be instructed to avoid taking rescue medications within 2 hours post-treatment. If medications are used, participants will be instructed to record in the app when and which medication was taken at 2- and 24-hours post treatment. The participants will use the app to record pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia l) as well as rate their stress level and functional disability at baseline, 2- and 24-hours post-treatment. At the beginning of each treatment, participants will also be asked to report the time elapsed from attack onset. Adverse events will be reported throughout this phase of the study directly to the site staff.

Participants who do not achieve satisfactory relief at 2 hours post-treatment may treat again with the Nerivio™ device or may treat with usual care at that time or any time thereafter if the headache does not resolve. Participants will also be able to treat headache recurrence with the device. Migraine headaches that are not treated with the device may be treated with usual care.

The first reported treatment will be considered a "training" treatment, aimed to verify that the participants use the device properly, and will only be included in the safety analysis. The efficacy evaluation will be performed on the first treatment of a qualifying attack (see below) following the training treatment (hereby termed "test treatment").

Second (final) visit - End of study:

Participants will return to the clinic following the end of the treatment phase, at which time they will return the device. The participants will have the option of returning the device by mail instead of an on-site visit.

Eligibility criteria: Inclusion Criteria:

1. Participants aged 18-75 years old.
2. Participants meeting the ICHD-3 diagnostic criteria for chronic migraine
3. Participants have personal access to a smartphone
4. Participants must be able and willing to comply with the protocol
5. Participants must be able and willing to provide written informed consent

Exclusion Criteria:

1. Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
2. Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
3. Participants with uncontrolled epilepsy.
4. Lack of efficacy, after an adequate therapeutic trial, of at least two migraine specific acute medications
5. Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study
6. Pregnant, trying to get pregnant or breastfeeding female participants
7. Subjects participating in any other interventional clinical study.
8. Participants without basic cognitive and motor skills needed to operate a smartphone
9. Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
10. Participants who have previous experience with the device

Primary outcomes:
measure: Proportion of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment
timeFrame: 2 hours post-treatment
Secondary outcomes:
measure: Proportion of Participants With Pain Disappearance at 2 Hours Post Treatment
timeFrame: 2 hours post treatment
measure: Proportion of Participants With Disappearance of Nausea and/or Vomiting at 2 Hours Post-treatment
timeFrame: 2 hours post treatment
measure: Proportion of Participants With Disappearance of Photophobia at 2 Hours Post-treatment
timeFrame: 2 hours post treatment
measure: Proportion of Participants With Disappearance of Phonophobia at 2 Hours Post-treatment
timeFrame: 2 hours post treatment
Other outcomes:
measure: Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments
timeFrame: 4 weeks
measure: Within-patient Consistency - Percentage of Participants Free of Headache Pain in at Least 50% of Their Treatments
timeFrame: 4 weeks
measure: Proportion of Participants With Improve Functional Disability at 2 Hours Post-treatment
timeFrame: 2 hours post treatment
measure: Proportion of Participants With Improve Functional Disability at 24 Hours Post-treatment
timeFrame: 24 hours post treatment
Locations:
city: Lagrangeville
country: United States
facility: Health Quest Medical Practice, PC
state: New York
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Nuvance Health
name: Paul Wright
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nierenburg H, Vieira JR, Lev N, Lin T, Harris D, Vizel M, Ironi A, Lewis B, Wright P. Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study. Pain Ther. 2020 Dec;9(2):531-543. doi: 10.1007/s40122-020-00185-1. Epub 2020 Jul 9.