A Study of Remote Electrical Neuromodulation for Acute Procedural Pain
TerminatedNot applicableNCT05730556
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Remote Electrical Neuromodulation for Acute Procedural Pain in Chronic Migraine Patients Receiving onabotulinumtoxinA
- Conditions
- Interventions
- Device: Nerivio ®
- Device: Sham
- Sponsor
- Mayo Clinic
- Start date
- 2023-02-13
- Primary completion
- 2024-09-09
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05730556