A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

September 30, 2025 updated by: Amaal J. Starling, M.D., Mayo Clinic

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical Neuromodulation, Then Sham
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 ®
Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.
Device: Sham
Electrical stimulation to mimic study treatment intervention
Experimental: Sham, Then Electrical Neuromodulation
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 ®
Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.
Device: Sham
Electrical stimulation to mimic study treatment intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time Frame: Baseline, Week 12, Week 24
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.
Baseline, Week 12, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 24 weeks
Number of adverse events reported
24 weeks
Presence of Post-procedural Headache
Time Frame: Baseline, Week 12, Week 24
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.
Baseline, Week 12, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Amaal Starling, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Actual)

September 9, 2024

Study Completion (Actual)

September 9, 2024

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-011180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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