A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the Nerivio ® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention.

Official Title
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Remote Electrical Neuromodulation for Acute Procedural Pain in Chronic Migraine Patients Receiving onabotulinumtoxinA

Conditions
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Chronic Migraine

Intervention / Treatment
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* Device: Nerivio ®
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the criteria for 1.3 chronic migraine based on ICHD3 criteria. Currently receiving onabotulinumtoxinA per PREEMPT protocol for the treatment of chronic migraine. Have remained stable on their current headache medication for a minimum of 8 weeks. Patient is willing and able to comply with the protocol to the satisfaction of the investigator. Patient has the capacity to provide written, informed consent for themselves. Exclusion Criteria: Participants with an active 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. 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 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. Patients with cranial deformities, prior cranial surgeries with violation of the calvarium, or shunt placement.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electrical Neuromodulation, Then Sham<br>Subjects will first have the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 12. Subjects will then have the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 24. | Device: Nerivio ®<br>* Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.<br>Device: Sham<br>* Electrical stimulation to mimic study treatment intervention<br>|
| Experimental: Sham, Then Electrical Neuromodulation<br>Subjects will first have the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 12. Subjects will then have the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continue to wear the device for a total of 40 to 45 minutes at week 24. | Device: Nerivio ®<br>* Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.<br>Device: Sham<br>* Electrical stimulation to mimic study treatment intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity measured by Visual Analog Scale (VAS) | Measured by VAS values reported by participants using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with no pain on the left, and worst possible pain on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the No pain end, and the number of millimeters will be reported as the pain score. | Baseline, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of post-procedural headache | Number of subjects to report the presence of post-procedural headache, defined as a headache that lasts for 4 hours or more and is at least moderate in severity or during which abortive medications are used to treat the patient's head pain. | 1 day following procedure | 
| Adverse Events | Number of adverse events reported | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OnabotulinumtoxinA (Botox) injections