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Neuromodulation Device
Remote Electrical Stimulation for Procedural Pain
N/A
Recruiting
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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pain intensity measured by Visual Analog Scale (VAS)
Secondary outcome measures
Adverse Events
Presence of post-procedural headache
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
~2060
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,766,893 Total Patients Enrolled
10 Trials studying Migraine
81,806 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For whom is this clinical trial an appropriate option?
"Prospective candidates for this clinical trial must have chronic migraine, and be between 18-75 years old. The goal is to recruit 80 individuals in total."
Answered by AI
Is this clinical research open to participants over the age of forty-five?
"The eligibility requirements for this trial state that individuals aged 18 to 75 can apply. On the other hand, there are 46 studies dedicated solely to minors and 116 trials catered towards seniors."
Answered by AI
Are there any opportunities for individuals to join this trial at present?
"Affirmative, the details on clinicaltrials.gov demonstrate that this research trial is actively recruiting participants. The investigation began to be listed on February 1st 2023 and was most recently updated six days later; 80 patients are being sought at a single location."
Answered by AI
How many individuals have enrolled in this experiment?
"Affirmative. The research listed on clinicaltrials.gov confirms that this examination is presently recruiting patients, which was first advertised on February 1st 2023 and most recently edited on February 6th 2023. Eighty participants are needed across one location to partake in the study."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have exhausted multiple neurological specialists. I have been on dozers of treatment medications both prophylactic and acute. I do not smoke, rarely drink.
PatientReceived 2+ prior treatments
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