Chronic Migraine
Conditions
Keywords
OnabotulinumtoxinA (Botox) injections
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.
Interventions
DEVICENerivio ®
Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm.
DEVICESham
Electrical stimulation to mimic study treatment intervention
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline, Week 12, Week 24 | 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. Scores can range from 0 to 100, with higher score indicating worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Post-procedural Headache | Baseline, Week 12, Week 24 | 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 | 24 weeks | Number of adverse events reported |
Countries
United States
Participant flow
Pre-assignment details
80 participants were consented to the study and of those 80 participants, 20 were withdrawn prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Electrical Neuromodulation, Then Sham Subjects first had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued 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 | 30 |
| Sham, Then Electrical Neuromodulation Subjects first had the sham device applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued to wear the device for a total of 40 to 45 minutes at week 12. Subjects then had the Nerivio ® applied 20 minutes prior to clinical care onabotulinumtoxinA (Botox) injection, and continued 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Sham, Then Electrical Neuromodulation | Total | Electrical Neuromodulation, Then Sham |
|---|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 15 | 48.0 years STANDARD_DEVIATION 14 | 51.5 years STANDARD_DEVIATION 12.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 23 Participants | 49 Participants | 26 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
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. Scores can range from 0 to 100, with higher score indicating worse pain.
Time frame: Baseline, Week 12, Week 24
Population: Seven (7) participants in the Electrical Neuromodulation, Then Sham arm and Eight (8) participants in Sham, Then Electrical Neuromodulation arm did not have Week 24 data as the trial was stopped early as the stopping rule for efficiency was reached in the interim analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electrical Neuromodulation, Then Sham | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline Intra-Procedure | 52.5 score on a scale | Standard Deviation 19.6 |
| Electrical Neuromodulation, Then Sham | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 12 Post-Procedure | 38.7 score on a scale | Standard Deviation 19.7 |
| Electrical Neuromodulation, Then Sham | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 12 Pre-Procedure | 21.2 score on a scale | Standard Deviation 23.3 |
| Electrical Neuromodulation, Then Sham | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 24 Pre-Procedure | 19.2 score on a scale | Standard Deviation 24.7 |
| Electrical Neuromodulation, Then Sham | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline Post-Procedure | 59.9 score on a scale | Standard Deviation 22.1 |
| Electrical Neuromodulation, Then Sham | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 24 Intra-Procedure | 50.4 score on a scale | Standard Deviation 20.5 |
| Electrical Neuromodulation, Then Sham | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 12 Intra-Procedure | 37.2 score on a scale | Standard Deviation 19.3 |
| Electrical Neuromodulation, Then Sham | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 24 Post-Procedure | 54.6 score on a scale | Standard Deviation 23.4 |
| Electrical Neuromodulation, Then Sham | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline Pre-Procedure | 23.0 score on a scale | Standard Deviation 26.3 |
| Sham, Then Electrical Neuromodulation | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 24 Post-Procedure | 46.6 score on a scale | Standard Deviation 25.3 |
| Sham, Then Electrical Neuromodulation | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline Pre-Procedure | 32.9 score on a scale | Standard Deviation 24.8 |
| Sham, Then Electrical Neuromodulation | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline Intra-Procedure | 58.3 score on a scale | Standard Deviation 24.2 |
| Sham, Then Electrical Neuromodulation | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Baseline Post-Procedure | 62.0 score on a scale | Standard Deviation 25.2 |
| Sham, Then Electrical Neuromodulation | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 12 Pre-Procedure | 27.0 score on a scale | Standard Deviation 23.7 |
| Sham, Then Electrical Neuromodulation | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 12 Intra-Procedure | 60.7 score on a scale | Standard Deviation 20.6 |
| Sham, Then Electrical Neuromodulation | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 12 Post-Procedure | 64.7 score on a scale | Standard Deviation 21.5 |
| Sham, Then Electrical Neuromodulation | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 24 Pre-Procedure | 25.7 score on a scale | Standard Deviation 20.3 |
| Sham, Then Electrical Neuromodulation | Change in Pain Intensity Measured by Visual Analog Scale (VAS) | Week 24 Intra-Procedure | 44.5 score on a scale | Standard Deviation 22.8 |
Secondary
Adverse Events
Number of adverse events reported
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electrical Neuromodulation, Then Sham | Adverse Events | 0 events |
| Sham, Then Electrical Neuromodulation | Adverse Events | 0 events |
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.
Time frame: Baseline, Week 12, Week 24
Population: Seven (7) participants in the Electrical Neuromodulation, Then Sham arm and Eight (8) participants in Sham, Then Electrical Neuromodulation arm did not have Week 24 data as the trial was stopped early as the stopping rule for efficiency was reached in the interim analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Electrical Neuromodulation, Then Sham | Presence of Post-procedural Headache | Baseline | 12 Participants |
| Electrical Neuromodulation, Then Sham | Presence of Post-procedural Headache | Week 12 | 4 Participants |
| Electrical Neuromodulation, Then Sham | Presence of Post-procedural Headache | Week 24 | 9 Participants |
| Sham, Then Electrical Neuromodulation | Presence of Post-procedural Headache | Baseline | 11 Participants |
| Sham, Then Electrical Neuromodulation | Presence of Post-procedural Headache | Week 12 | 20 Participants |
| Sham, Then Electrical Neuromodulation | Presence of Post-procedural Headache | Week 24 | 4 Participants |