Your session is about to expire
← Back to Search
Neuromodulation Device
Remote Electrical Stimulation for Procedural Pain
N/A
Waitlist Available
Led By Amaal Starling, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial studies whether using a device to apply electrical stimulation can reduce pain from Botox injections for migraine prevention.
Who is the study for?
This trial is for chronic migraine sufferers who've been stable on their current headache medication for at least 8 weeks and are receiving Botox injections for prevention. They must be able to follow the study rules and give written consent. People with implanted electrical devices, severe heart conditions, uncontrolled epilepsy, recent changes in migraine meds, pregnant or breastfeeding women, or those in other studies can't join.
What is being tested?
The study tests if a device called Nerivio ® can help reduce pain when patients get Botox injections for chronic migraines. Participants will either use this remote electrical neuromodulation device or a sham (fake) version to see which is more effective.
What are the potential side effects?
Potential side effects of using the Nerivio ® device may include skin irritation where it's applied, mild electric sensation during use that should not be painful but might feel uncomfortable to some people.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks, 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks, 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pain intensity measured by Visual Analog Scale (VAS)
Secondary study objectives
Adverse Events
Presence of post-procedural headache
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sham, Then Electrical NeuromodulationExperimental Treatment2 Interventions
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.
Group II: Electrical Neuromodulation, Then ShamExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham
2013
Completed Phase 3
~2090
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,414 Total Patients Enrolled
11 Trials studying Migraine
82,006 Patients Enrolled for Migraine
Amaal Starling, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe heart or blood vessel problems.You have epilepsy that is not being well managed.You have changed the type or dose of your migraine prevention medication in the past two months before joining the study or during the study.You have used the device before.You have had surgery on your head that affected the skull or have a shunt in your head.You have chronic migraines based on specific medical criteria.You are currently getting onabotulinumtoxinA treatment for chronic migraine according to the PREEMPT protocol.You have other serious pain, medical, or psychological issues that could make it hard to understand the study.
Research Study Groups:
This trial has the following groups:- Group 1: Sham, Then Electrical Neuromodulation
- Group 2: Electrical Neuromodulation, Then Sham
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Migraine Patient Testimony for trial: Trial Name: NCT05730556 — N/A
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger