Trial Outcomes & Findings for A Study of Remote Electrical Neuromodulation for Acute Procedural Pain (NCT NCT05730556)
NCT ID: NCT05730556
Last Updated: 2025-10-27
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Baseline, Week 12, Week 24
Results posted on
2025-10-27
Participant Flow
80 participants were consented to the study and of those 80 participants, 20 were withdrawn prior to randomization.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
First Intervention
STARTED
|
30
|
30
|
|
First Intervention
COMPLETED
|
30
|
30
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
30
|
30
|
|
Second Intervention
COMPLETED
|
30
|
30
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Electrical Neuromodulation, Then Sham
n=30 Participants
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
|
Sham, Then Electrical Neuromodulation
n=30 Participants
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
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 12.2 • n=30 Participants
|
44.5 years
STANDARD_DEVIATION 15.0 • n=30 Participants
|
48.0 years
STANDARD_DEVIATION 14.0 • n=60 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
49 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
60 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12, Week 24Population: 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.
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.
Outcome measures
| Measure |
Electrical Neuromodulation, Then Sham
n=30 Participants
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
|
Sham, Then Electrical Neuromodulation
n=30 Participants
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
|
|---|---|---|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Baseline Post-Procedure
|
59.9 score on a scale
Standard Deviation 22.1
|
62.0 score on a scale
Standard Deviation 25.2
|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Week 12 Pre-Procedure
|
21.2 score on a scale
Standard Deviation 23.3
|
27.0 score on a scale
Standard Deviation 23.7
|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Week 12 Post-Procedure
|
38.7 score on a scale
Standard Deviation 19.7
|
64.7 score on a scale
Standard Deviation 21.5
|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Week 24 Pre-Procedure
|
19.2 score on a scale
Standard Deviation 24.7
|
25.7 score on a scale
Standard Deviation 20.3
|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Week 24 Intra-Procedure
|
50.4 score on a scale
Standard Deviation 20.5
|
44.5 score on a scale
Standard Deviation 22.8
|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Week 24 Post-Procedure
|
54.6 score on a scale
Standard Deviation 23.4
|
46.6 score on a scale
Standard Deviation 25.3
|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Baseline Pre-Procedure
|
23.0 score on a scale
Standard Deviation 26.3
|
32.9 score on a scale
Standard Deviation 24.8
|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Baseline Intra-Procedure
|
52.5 score on a scale
Standard Deviation 19.6
|
58.3 score on a scale
Standard Deviation 24.2
|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Week 12 Intra-Procedure
|
37.2 score on a scale
Standard Deviation 19.3
|
60.7 score on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: 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.
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.
Outcome measures
| Measure |
Electrical Neuromodulation, Then Sham
n=30 Participants
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
|
Sham, Then Electrical Neuromodulation
n=30 Participants
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
|
|---|---|---|
|
Presence of Post-procedural Headache
Baseline
|
12 Participants
|
11 Participants
|
|
Presence of Post-procedural Headache
Week 12
|
4 Participants
|
20 Participants
|
|
Presence of Post-procedural Headache
Week 24
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 weeksNumber of adverse events reported
Outcome measures
| Measure |
Electrical Neuromodulation, Then Sham
n=60 Participants
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
|
Sham, Then Electrical Neuromodulation
n=60 Participants
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
|
|---|---|---|
|
Adverse Events
|
0 events
|
0 events
|
Adverse Events
Electrical Neuromodulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place