An interventional study of Nerivio in Chronic Migraine, sponsored by Theranica. Completed at 10 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Theranica · Not applicable, Interventional, and Treatment
A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases:
Phase I - Run-in:
Eligible participants will be trained to use a smartphone migraine diary application. During the 4 weeks of this phase, participants will be instructed to report all their migraines and headaches at onset, 2 hours and 24 hours post report .
Phase II - Treatment:
A 4-week treatment phase in which participants will be asked to treat their migraine headaches with the Nerivio device and report it using the smartphone application at baseline, 2 hours and 24 hours post-treatment.
Phase III - Follow-up:
An 8-week follow-up phase in which participants will incorporate the Nerivio device into their usual care according to their preference (Nerivio only, medication only, both or none). Participants will be asked to report all their migraines or headaches at onset, 2 hours post report and 24 hours post report.
This open label study includes up to four visits. The enrollment and application training may occur in two separate visits instead of one.
First visit - The first visit will include screening, enrollment and training on the application.
Enrollment: The screening process will include an eligibility assessment and a urine pregnancy test. Following successful screening, the site staff will provide the participants with study related information, perform an enrollment interview and receive an informed consent from the participants. During this visit, participants will complete baseline questionnaires that included information on the frequency and severity of their migraine attacks, typical associated symptoms, use of preventive and acute treatments, and the effect that their migraine attacks have on their daily routine and quality of life.
Application training: Eligible participants who enroll to the study will be trained to use the diary mode of the application that is installed on their own smartphones. The participants will be instructed to report the onset of all their migraines and headaches and complete a migraine diary questions regarding their pain intensity levels, the presence/absence of aura and associated migraine symptoms (nausea, photophobia, phonophobia, and allodynia) 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. The site personnel will be required to document the training session in the Case Report Form (CRF).
Run-in phase: After the enrollment visit, participants will undergo a 4-week migraine diary phase aimed to collect baseline migraine characteristics and further assess eligibility. 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) as well as the effect that their migraine attacks have on their daily routine and quality of life, at baseline, 2- and 24-hours post-treatment. These reports will be transferred by the application to the electronic data capture (EDC) system, where they will be collected and registered.
Participants who report at least 6 qualifying migraine headaches with pain data at baseline and 2 hours post-treatment will continue to the treatment phase.
Second visit- Device training: Eligible participants who successfully complete the run-in phase will receive the Nerivio™ device. The device will be registered and connected by Bluetooth to their smartphone. During this visit, participants will be trained to use the device. Device training will include finding the optimal individual stimulation intensity level (perceptible but not painful), that will be subject to change during the treatment phase. The site staff will also carefully review with the patient how to identify a qualifying migraine headache (see below) and provide detailed instructions on study procedures.
If the research staff recognizes that the participant cannot tolerate the feeling of the electrical stimulation, the participant may be withdrawn from the study.
During the training, participants will also be informed on the key elements which are critical for the successful conduct of the study:
The site personnel will be required to document the training session in the CRF.
Treatment phase: Participants will be instructed to use the device for the treatment of migraine and/or 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) as well as the effect that their migraine attacks have on their daily routine and quality of life, 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").
Third visit- Follow-up phase:
Following the 4-week period of the treatment phase, participants will return to the clinic to fill questionnaires assessing satisfaction and user experience. All participants who complete the treatment phase will enter an additional 8-week phase in which the device can be incorporate into their usual care. Participants will treat their migraines and headaches according to their preference- treatment with Nerivio only, treatment with medication only, both treatment options, or none. Participants will be asked to report all their migraine headaches at onset (migraines or headache), regardless if they are using the device or not. 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) as well as the effect that their migraine attacks have on their daily routine and quality of life, at baseline, 2- and 24-hours post-treatment.
Fourth (final) visit - End of study:
Participants will return to the clinic following the end of the follow-up 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. Participants may be asked to fill additional questionnaires on their migraine and their experience with the device.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 126 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Theranica is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with active Nerivio device
Device: Nerivio
A remote electrical neuromodulation (REN) device for the acute treatment of migraines.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.
Pain Relief at 2 Hours Post-treatment
The proportion of subjects reporting, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
Time frame: 2 hours post-treatment
Pain-free at 2 Hours Post-treatment
The proportion of subjects reporting, for the test treatment, no pain at 2 hours post-treatment without the use of rescue medication. Pain-free is defined as improvement from mild, moderate, or severe pain to none. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
Time frame: 2 hours post-treatment
Disappearance of Nausea at 2 Hours Post-treatment
The proportion of subjects presented nausea at the migraine onset and reported disappearance of nausea at 2 hours post-treatment of the test treatment
Time frame: 2 hours post treatment
Disappearance of Photophobia at 2 Hours Post-treatment
The proportion of subjects presented photohobia at the migraine onset and reported disappearance of photophobia at 2 hours post-treatment of the test treatment
Time frame: 2 hours post treatment
Disappearance of Phonophobia at 2 Hours Post-treatment
The proportion of subjects presented phonophobia at the migraine onset and reported disappearance of phonophobia at 2 hours post-treatment of the test treatment
Time frame: 2 hours post treatment
Within-subject Consistency of the Pain Relief Response
proportion of patients achieving pain relief at 2 hours in at least 50% of all their treatments
Time frame: throughout the study
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
Time frame: 2 hours post treatment
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
Time frame: 24 hours post treatment
Sustained Pain Relief at 24 Hours Post-treatment
The proportion of subjects achieving, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication and no relapse of headache pain within 24 hours
Time frame: 24 hours post treatment
| Milestone | Nerivio Device Treatment |
|---|---|
| Started | 126 |
| Completed | 99 |
| Not completed | 27 |
| Withdrew: Fail to comply with run-in phase criteria | 19 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Lost to follow-up | 2 |
| Milestone | Nerivio Device Treatment |
|---|---|
| Started | 99 |
| Completed | 91 |
| Not completed | 8 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Missing data | 4 |
| Withdrew: Lost to follow-up | 1 |
The proportion of subjects reporting, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication. Pain relief is defined as an improvement from severe or moderate pain to mild or no pain, or from mild pain to no pain. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
| Participants | Nerivio Device Treatment |
|---|---|
| Pain Relief at 2 Hours Post-treatment | 54 |
The proportion of subjects reporting, for the test treatment, no pain at 2 hours post-treatment without the use of rescue medication. Pain-free is defined as improvement from mild, moderate, or severe pain to none. Pain level will be reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain, 3- Severe pain)
| Participants | Nerivio Device Treatment |
|---|---|
| Pain-free at 2 Hours Post-treatment | 19 |
The proportion of subjects presented nausea at the migraine onset and reported disappearance of nausea at 2 hours post-treatment of the test treatment
| Participants | Nerivio Device Treatment |
|---|---|
| Disappearance of Nausea at 2 Hours Post-treatment | 20 |
The proportion of subjects presented photohobia at the migraine onset and reported disappearance of photophobia at 2 hours post-treatment of the test treatment
| Participants | Nerivio Device Treatment |
|---|---|
| Disappearance of Photophobia at 2 Hours Post-treatment | 30 |
The proportion of subjects presented phonophobia at the migraine onset and reported disappearance of phonophobia at 2 hours post-treatment of the test treatment
| Participants | Nerivio Device Treatment |
|---|---|
| Disappearance of Phonophobia at 2 Hours Post-treatment | 29 |
proportion of patients achieving pain relief at 2 hours in at least 50% of all their treatments
| Participants | Nerivio Device Treatment |
|---|---|
| Within-subject Consistency of the Pain Relief Response | 52 |
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
| Participants | Nerivio Device Treatment |
|---|---|
| Functional Disability at 2 Hours Post-treatment | 19 |
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
| Participants | Nerivio Device Treatment |
|---|---|
| Functional Disability at 24 Hours Post-treatment | 7 |
The proportion of subjects achieving, for the test treatment, pain relief at 2 hours post-treatment without the use of rescue medication and no relapse of headache pain within 24 hours
| Participants | Nerivio Device Treatment |
|---|---|
| Sustained Pain Relief at 24 Hours Post-treatment | 33 |
Collected over Up to 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nerivio Device Treatment | 0/99 (0%) | 0/99 (0%) | 9/99 (9.1%) |
| Event | Nerivio Device Treatment |
|---|---|
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 2/99 |
| Pain in the armNervous system disorders | 1/99 |
| Sinus infectionInfections and infestations | 1/99 |
| Ear infectionInfections and infestations | 1/99 |
| viral infectioniral infectionInfections and infestations | 1/99 |
| Tooth infectionInfections and infestations | 1/99 |
| Leg painNervous system disorders | 1/99 |
| Poison ivy rashSkin and subcutaneous tissue disorders | 1/99 |
| Age, Continuous(years) | Nerivio Device Treatment |
|---|---|
| Mean | 44.3 ± 13.7 |
| Sex: Female, Male(Participants) | Nerivio Device Treatment |
|---|---|
| Female | 110 |
| Male | 16 |
| Race (NIH/OMB)(Participants) | Nerivio Device Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 115 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Average number of headache days per month(Days) | Nerivio Device Treatment |
|---|---|
| Mean | 18.8 ± 2.7 |
| Average number of migraine headache days per month(Days) | Nerivio Device Treatment |
|---|---|
| Mean | 16.4 ± 3.7 |
| Use of preventive medication(Participants) | Nerivio Device Treatment |
|---|---|
| Count of participants | 80 |
| Migraine with aura(Participants) | Nerivio Device Treatment |
|---|---|
| Count of participants | 36 |
| Triptan usage(Participants) | Nerivio Device Treatment |
|---|---|
| Count of participants | 49 |
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