A Study of Remote Electrical Neuromodulation for Acute Procedural Pain
NCT ID: NCT05730556
Last Updated: 2025-10-27
Study Results
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View full resultsBasic Information
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TERMINATED
NA
80 participants
INTERVENTIONAL
2023-02-13
2024-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Electrical Neuromodulation, Then Sham
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.
Nerivio ®
Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.
Sham
Electrical stimulation to mimic study treatment intervention
Sham, Then Electrical Neuromodulation
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.
Nerivio ®
Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.
Sham
Electrical stimulation to mimic study treatment intervention
Interventions
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Nerivio ®
Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.
Sham
Electrical stimulation to mimic study treatment intervention
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
* 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
18 Years
75 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Amaal J. Starling, M.D.
Principal Investigator
Principal Investigators
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Amaal Starling, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-011180
Identifier Type: -
Identifier Source: org_study_id
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