A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

Mayo Clinic

Status: Terminated

Conditions: Chronic Migraine

Treatments: Device: Sham; Device: Nerivio ®

Study type: Interventional

Funder types: Other

Identifiers

NCT05730556

22-011180

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Electrical Neuromodulation, Then Sham

Experimental group

Description:

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:

Device: Nerivio ®

Device: Sham

Sham, Then Electrical Neuromodulation

Experimental group

Description:

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.

Treatment:

Device: Nerivio ®

Device: Sham