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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerivio device treatment | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerivio | Device | The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment | The proportion of participants reporting pain relief at 2 hours post-treatment without the use of rescue medication following the test treatment . Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. | 2 hours post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Pain Disappearance at 2 Hours Post Treatment | The proportion of participants reporting freedom from migraine pain at 2 hours post-treatment without medications following the test treatment. Pain freedom is defined as an improvement from severe or moderate or mild pain to no pain | 2 hours post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments | Proportions of participants achieving pain relief at 2 hours in at least 50% of all their treatments (excluding the training treatment) | 4 weeks |
| Within-patient Consistency - Percentage of Participants Free of Headache Pain in at Least 50% of Their Treatments |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Wright | Nuvance Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Quest Medical Practice, PC | Lagrangeville | New York | 12540 | United States | ||
| Meir Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32648205 | Derived | 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. |
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This study was conducted from September 18, 2019 to February 18, 2020. . Study sites were Nuvance health (Poughkeepsie, NY) and Meir Medical center (Kefar Sava, Israel). 42 patients were enrolled and received a device. Two participants withdrew from the study.
All participants completed at least one treatment (the training treatment) and 38 participants completed the test treatment, forming the final analysis set.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nerivio Device Treatment | 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 Nerivio: The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nerivio Device Treatment | 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 Nerivio: The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment | The proportion of participants reporting pain relief at 2 hours post-treatment without the use of rescue medication following the test treatment . Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. | Posted | Count of Participants | Participants | 2 hours post-treatment |
|
Up to 4 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body.The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as theexclusion criteria for the study leave out participant with electrical implant,congenital heart failure or epilepsy, the number of high risk participants is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nerivio Device Treatment | 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 Nerivio: The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
No limitations or caveats were reported
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Dagan Harris. VP Clinical @Regulatory Affairs | Theranica Bio-Electronics Ltd | 0542220121 | daganh@theranica.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2019 | Dec 15, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2019 | Dec 15, 2020 | ICF_001.pdf |
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| Proportion of Participants With Disappearance of Nausea and/or Vomiting at 2 Hours Post-treatment |
The proportion of participants reporting disappearance of nausea and/or vomiting at 2 hours post-treatment without rescue medications following the test treatment. |
| 2 hours post treatment |
| Proportion of Participants With Disappearance of Photophobia at 2 Hours Post-treatment | The proportion of participants reporting disappearance of photophobia at 2 hours post-treatment without rescue medications following the test treatment. | 2 hours post treatment |
| Proportion of Participants With Disappearance of Phonophobia at 2 Hours Post-treatment | The proportion of participants reporting disappearance phonophobia at 2 hours post-treatment without rescue medications following the test treatment. | 2 hours post treatment |
Proportion of participants achieving pain free at 2 hours in at least 50% of all their treatments (excluding the training treatment) |
| 4 weeks |
| Proportion of Participants With Improve Functional Disability at 2 Hours Post-treatment | The proportion of participants achieving improvement of at least one grade in functional disability in the test treatment at 2 hours post-treatment with no use of rescue medication. the scale used was: (0) No limitation, (1) Some limitation, (2) Moderate limitation and (3) Severe limitation. | 2 hours post treatment |
| Proportion of Participants With Improve Functional Disability at 24 Hours Post-treatment | The proportion of participants achieving improvement of at least one grade in functional disability in the test treatment at 24 hours post-treatment with no use of rescue medication. the scale used was: (0) No limitation, (1) Some limitation, (2) Moderate limitation and (3) Severe limitation. | 24 hours post treatment |
| Kfar Saba |
| 4428164 |
| Israel |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Average number of headache days per month | Mean | Standard Deviation | Days per month |
|
| Average number of migraine headache das per month | Mean | Standard Deviation | Days per month |
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| Use of preventive medication | Count of Participants | Participants |
|
|
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| Secondary | Proportion of Participants With Pain Disappearance at 2 Hours Post Treatment | The proportion of participants reporting freedom from migraine pain at 2 hours post-treatment without medications following the test treatment. Pain freedom is defined as an improvement from severe or moderate or mild pain to no pain | Posted | Count of Participants | Participants | 2 hours post treatment |
|
|
|
| Secondary | Proportion of Participants With Disappearance of Nausea and/or Vomiting at 2 Hours Post-treatment | The proportion of participants reporting disappearance of nausea and/or vomiting at 2 hours post-treatment without rescue medications following the test treatment. | only 17 participants reported nausea and/or vomiting at T=0 hours of the Test treatment | Posted | Count of Participants | Participants | 2 hours post treatment |
|
|
|
| Secondary | Proportion of Participants With Disappearance of Photophobia at 2 Hours Post-treatment | The proportion of participants reporting disappearance of photophobia at 2 hours post-treatment without rescue medications following the test treatment. | only 24 participants reported photophobia at T=0 hours of the Test treatment | Posted | Count of Participants | Participants | 2 hours post treatment |
|
|
|
| Secondary | Proportion of Participants With Disappearance of Phonophobia at 2 Hours Post-treatment | The proportion of participants reporting disappearance phonophobia at 2 hours post-treatment without rescue medications following the test treatment. | only 16 participants reported phonophobia at T=0 hours of the Test treatment | Posted | Count of Participants | Participants | 2 hours post treatment |
|
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| Other Pre-specified | Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments | Proportions of participants achieving pain relief at 2 hours in at least 50% of all their treatments (excluding the training treatment) | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Other Pre-specified | Within-patient Consistency - Percentage of Participants Free of Headache Pain in at Least 50% of Their Treatments | Proportion of participants achieving pain free at 2 hours in at least 50% of all their treatments (excluding the training treatment) | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Other Pre-specified | Proportion of Participants With Improve Functional Disability at 2 Hours Post-treatment | The proportion of participants achieving improvement of at least one grade in functional disability in the test treatment at 2 hours post-treatment with no use of rescue medication. the scale used was: (0) No limitation, (1) Some limitation, (2) Moderate limitation and (3) Severe limitation. | Only 30 participants reported their function disability level at T=0 hours and T=2 hours for their test treatment | Posted | Count of Participants | Participants | 2 hours post treatment |
|
|
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| Other Pre-specified | Proportion of Participants With Improve Functional Disability at 24 Hours Post-treatment | The proportion of participants achieving improvement of at least one grade in functional disability in the test treatment at 24 hours post-treatment with no use of rescue medication. the scale used was: (0) No limitation, (1) Some limitation, (2) Moderate limitation and (3) Severe limitation. | Only 19 participants reported their function disability level at T=0 hours and T=24 hours for their test treatment | Posted | Count of Participants | Participants | 24 hours post treatment |
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| 0 |
| 42 |
| 0 |
| 42 |
| 1 |
| 42 |
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