A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nerivio ®

Sham

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring OnabotulinumtoxinA (Botox) injections

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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. 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.

Sites / Locations

Mayo Clinic in ArizonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Electrical Neuromodulation, Then Sham

Sham, Then Electrical Neuromodulation

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Adverse Events

Number of adverse events reported

Full Information

NCT ID

NCT05730556

First Posted

February 6, 2023

Last Updated

June 26, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05730556

Brief Title

A Study of Remote Electrical Neuromodulation for Acute Procedural Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 13, 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Migraine

Keywords

OnabotulinumtoxinA (Botox) injections

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electrical Neuromodulation, Then Sham

Arm Type

Experimental

Arm 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.

Arm Title

Sham, Then Electrical Neuromodulation

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

Nerivio ®

Intervention Description

Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.

Intervention Type

Device

Intervention Name(s)

Sham

Intervention Description

Electrical stimulation to mimic study treatment intervention

Primary Outcome Measure Information:

Title

Change in pain intensity measured by Visual Analog Scale (VAS)

Description

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.

Time Frame

Baseline, 12 weeks, 24 weeks

Secondary Outcome Measure Information:

Title

Presence of post-procedural headache

Description

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.

Time Frame

1 day following procedure

Title

Adverse Events

Description

Number of adverse events reported

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meka Simmons

Phone

480-301-9224

Email

simmons.temeka@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amaal Starling, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie Ruiz Morales, MPH

Phone

480-301-4282

Email

ruizmorales.stephanie@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD

No

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Chronic Migraine

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial