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Enough data was collected to demonstrate device efficacy at interim analysis
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical Neuromodulation, Then Sham | Experimental | 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. |
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| Sham, Then Electrical Neuromodulation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerivio ® | Device | Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12, Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amaal Starling, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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80 participants were consented to the study and of those 80 participants, 20 were withdrawn prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, Week 24 |
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Adverse Events were collected from the time of informed consent through study completion, approximately 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electrical Neuromodulation | Subjects 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. Nerivio ®: Non-invasive wearable, remote electrical neuromodulation (REN) device controlled by a smartphone application worn on an armband on the upper arm. |
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This study was terminated early as enough data was collected at interim analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amaal Starling, M.D. | Mayo Clinic | 715-537-1345 | Starling.Amaal@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2023 | Jul 22, 2025 | Prot_SAP_000.pdf |
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| Sham | Device | Electrical stimulation to mimic study treatment intervention |
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| Adverse Events |
Number of adverse events reported |
| 24 weeks |
| NOT COMPLETED |
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| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 |
| OG001 | 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 |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24 |
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| Secondary | Adverse Events | Number of adverse events reported | Posted | Number | events | 24 weeks |
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Sham | Subjects 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. Sham: Electrical stimulation to mimic study treatment intervention | 0 | 60 | 0 | 60 | 0 | 60 |
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| Week 12 |
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| Week 24 |
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