A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

Mayo Clinic80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Migraine

Interventions

Nerivio ®DEVICE

Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.

ShamDEVICE

Electrical stimulation to mimic study treatment intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. * 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. * 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. * Patients receiving concurrent nerve blocks or trigger point injections within the same visit

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

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. Scores can range from 0 to 100, with higher score indicating worse pain.

Time frame: Baseline, Week 12, Week 24

Secondary Outcomes

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.

Time frame: Baseline, Week 12, Week 24

Adverse Events

Number of adverse events reported

Time frame: 24 weeks

Data from ClinicalTrials.gov

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