A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

NCT05730556 | Terminated Results FDA Device

• 1 other identifier: 22-011180
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Migraine

Keywords

OnabotulinumtoxinA (Botox) injections

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12, Week 24

Secondary Outcomes (2)

• Presence of Post-procedural Headache

  Baseline, Week 12, Week 24

• Adverse Events

  24 weeks

Study Arms (2)

Electrical Neuromodulation, Then Sham

EXPERIMENTAL

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 ®; Device: Sham

Sham, Then Electrical Neuromodulation

EXPERIMENTAL

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 ®; Device: Sham

Interventions

Nerivio ® DEVICE

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

Electrical Neuromodulation, Then Sham; Sham, Then Electrical Neuromodulation

Sham DEVICE

Electrical stimulation to mimic study treatment intervention

Electrical Neuromodulation, Then Sham; Sham, Then Electrical Neuromodulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Limitations and Caveats

This study was terminated early as enough data was collected at interim analysis.

Results Point of Contact

• Title: Amaal Starling, M.D.
• Organization: Mayo Clinic

Starling.Amaal@mayo.edu

715-537-1345

Study Officials

• Amaal Starling, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 16, 2023
• Study Start: February 13, 2023
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)