NCT05730556

A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

Terminated NA Results posted Last updated 27 October 2025

What this trial tests

NA trial testing Nerivio ® in Chronic Migraine in 80 participants. Terminated before completion.

Timeline

13 February 2023

Primary endpoint
9 September 2024

9 September 2024

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	13 February 2023
Primary completion	9 September 2024
Estimated completion	9 September 2024
Sites	1 location across United States

Drugs / interventions tested

• Nerivio ®
• Sham

Conditions studied

• Chronic Migraine — all drugs for Chronic Migraine →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 75, any sex, with Chronic Migraine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain Intensity Measured by Visual Analog Scale (VAS) Primary · 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 Pre-Procedure

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	23.0	± 26.3
Sham, Then Electrical Neuromodulation	32.9	± 24.8

Baseline Intra-Procedure

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	52.5	± 19.6
Sham, Then Electrical Neuromodulation	58.3	± 24.2

Baseline Post-Procedure

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	59.9	± 22.1
Sham, Then Electrical Neuromodulation	62.0	± 25.2

Week 12 Pre-Procedure

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	21.2	± 23.3
Sham, Then Electrical Neuromodulation	27.0	± 23.7

Week 12 Intra-Procedure

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	37.2	± 19.3
Sham, Then Electrical Neuromodulation	60.7	± 20.6

Week 12 Post-Procedure

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	38.7	± 19.7
Sham, Then Electrical Neuromodulation	64.7	± 21.5

Week 24 Pre-Procedure

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	19.2	± 24.7
Sham, Then Electrical Neuromodulation	25.7	± 20.3

Week 24 Intra-Procedure

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	50.4	± 20.5
Sham, Then Electrical Neuromodulation	44.5	± 22.8

Presence of Post-procedural Headache Secondary · 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

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	12
Sham, Then Electrical Neuromodulation	11

Week 12

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	4
Sham, Then Electrical Neuromodulation	20

Week 24

Group	Value	95% CI
Electrical Neuromodulation, Then Sham	9
Sham, Then Electrical Neuromodulation	4

Adverse Events Secondary · 24 weeks

Number of adverse events reported

Group	Value	95% CI
Electrical Neuromodulation	0
Sham, Then Electrical Neuromodulation	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.