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A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

NCT05730556 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-27

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Amaal Starling, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2024-09-09
Completion
2024-09-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05730556 on ClinicalTrials.gov