Chronic MigraineNCT05730556

A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

A study testing Nerivio ® in people with Chronic Migraine, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Migraine
What is being tested?: Nerivio ®
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 13 Feb 2023to 9 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259

Other trials in United States

About this study

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

Conditions: Chronic Migraine
Being tested: Nerivio ®, Sham
Keywords: OnabotulinumtoxinA (Botox) injections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05730556
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Nerivio ®; Device: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 12, Week 24

Secondary outcomes (2)

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.
Measured: Baseline, Week 12, Week 24
Adverse Events
Number of adverse events reported
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 20239 Sep 2024

First posted16 Feb 2023
Study start13 Feb 2023
Primary completion9 Sep 2024
Study completion9 Sep 2024

Why it stopped: Enough data was collected to demonstrate device efficacy at interim analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic MigraineStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05730556
Sponsor's protocol ID: 22-011180
Status last verified: Sep 2025
First submitted: 6 Feb 2023
Last updated: 27 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Active, not recruiting
MMA Embolization for Refractory Chronic Migraine
Migraine Disorders
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine

All Chronic Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remote Electrical Neuromodulation for Acute Procedural Pain in Chronic Migraine Patients Receiving onabotulinumtoxinA
ClinicalTrials.gov ID: NCT05730556
Acronym / sponsor ID: 22-011180
Conditions: Chronic Migraine
Keywords: OnabotulinumtoxinA (Botox) injections
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enough data was collected to demonstrate device efficacy at interim analysis
Enrolment: 80 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 13 Feb 2023 (actual)
Primary completion: 9 Sep 2024 (actual)
Study completion: 9 Sep 2024 (actual)
First posted: 16 Feb 2023 (actual)
Results: Posted 27 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Electrical Neuromodulation, Then Sham	Experimental	Device: Nerivio ®, Device: ShamSubjects 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.
Sham, Then Electrical Neuromodulation	Experimental	Device: Nerivio ®, Device: ShamSubjects 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nerivio ®Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.	Device	Electrical Neuromodulation, Then Sham, Sham, Then Electrical Neuromodulation
ShamElectrical stimulation to mimic study treatment intervention	Device	Electrical Neuromodulation, Then Sham, Sham, Then Electrical Neuromodulation

Primary outcome

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.

2 secondary outcomes

Presence of Post-procedural Headache
Time frame: Baseline, Week 12, Week 24
Adverse Events
Time frame: 24 weeks

Results and safety

Results posted to the registry on 27 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Electrical Neuromodulation, Then Sham	30	30
Sham, Then Electrical Neuromodulation	30	30

Primary outcome: Change in Pain Intensity Measured by Visual Analog Scale (VAS)

Time frame: Baseline, Week 12, Week 24. Mean (Standard Deviation). Unit: score on a scale

Measure	Electrical Neuromodulation, Then Sham n = 30	Sham, Then Electrical Neuromodulation n = 30
Baseline Pre-Procedure	23.0 (26.3)	32.9 (24.8)
Baseline Intra-Procedure	52.5 (19.6)	58.3 (24.2)
Baseline Post-Procedure	59.9 (22.1)	62.0 (25.2)
Week 12 Pre-Procedure	21.2 (23.3)	27.0 (23.7)
Week 12 Intra-Procedure	37.2 (19.3)	60.7 (20.6)
Week 12 Post-Procedure	38.7 (19.7)	64.7 (21.5)
Week 24 Pre-Procedure	19.2 (24.7)	25.7 (20.3)
Week 24 Intra-Procedure	50.4 (20.5)	44.5 (22.8)

Population analysed: Seven (7) participants in the Electrical Neuromodulation, Then Sham arm and Eight (8) participants in Sham, Then Electrical Neuromodulation arm did not have Week 24 data as the trial was stopped early as the stopping rule for efficiency was reached in the interim analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from the time of informed consent through study completion, approximately 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Electrical Neuromodulation	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Sham	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Limitations and caveats (from the sponsor): This study was terminated early as enough data was collected at interim analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Chronic Migraine

Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Active, not recruiting
MMA Embolization for Refractory Chronic Migraine
Migraine Disorders
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amaal Starling, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nerivio ® in people with Chronic Migraine, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Baseline, Week 12, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05730556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.