A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

Chronic Migraine Clinical Trial

Official title:

Remote Electrical Neuromodulation for Acute Procedural Pain in Chronic Migraine Patients Receiving onabotulinumtoxinA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730556
• Other study ID #: 22-011180
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Hannah Henderson
• Phone: 480-301-6091
• Email: henderson.hannah2[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

• Have remained stable on their current headache medication for a minimum of 8 weeks.

• 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.

• Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study.

• 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.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders
• Pain, Procedural

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity measured by Visual Analog Scale (VAS)	Measured by VAS values reported by participants using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.	Baseline, 12 weeks, 24 weeks
Secondary	Presence of post-procedural headache	Number of subjects to report the presence of post-procedural headache, defined as a headache that lasts for 4 hours or more and is at least moderate in severity or during which abortive medications are used to treat the patient's head pain.	1 day following procedure
Secondary	Adverse Events	Number of adverse events reported	24 weeks