Trial Outcomes & Findings for Evaluation of a Novel Device for Treatment of Migraine Headache (NCT NCT03361423)
NCT ID: NCT03361423
Last Updated: 2021-05-19
Results Overview
The percentage of patients reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their first treated migraine attack (excluding the "run-in test" treatment).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
296 participants
Primary outcome timeframe
2 hours post migraine onset
Results posted on
2021-05-19
Participant Flow
a 4 weeks "run-in" phase. during this phase, participants recorded their migraine attacks and complete a migraine diary at T=0,2 and 48 hours for each migraine attack. Participant who had 2-8 attacks and completed at least 66% of their migraine diary were eligible to continue to the treatment phase
Participant milestones
| Measure |
Treatment of Migraine With Active Device
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
Treatment of Migraine With Sham Device
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
126
|
|
Overall Study
COMPLETED
|
99
|
103
|
|
Overall Study
NOT COMPLETED
|
27
|
23
|
Reasons for withdrawal
| Measure |
Treatment of Migraine With Active Device
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
Treatment of Migraine With Sham Device
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Did not treat
|
19
|
18
|
|
Overall Study
Started >60 minutes from migraine onset
|
0
|
1
|
|
Overall Study
Missing data
|
4
|
1
|
Baseline Characteristics
Evaluation of a Novel Device for Treatment of Migraine Headache
Baseline characteristics by cohort
| Measure |
Treatment of Migraine With Active Device
n=126 Participants
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
Treatment of Migraine With Sham Device
n=126 Participants
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 12.25 • n=39 Participants
|
41.6 years
STANDARD_DEVIATION 11.81 • n=41 Participants
|
42.7 years
STANDARD_DEVIATION 12.06 • n=35 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=39 Participants
|
102 Participants
n=41 Participants
|
203 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
49 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=39 Participants
|
112 Participants
n=41 Participants
|
221 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
90 Participants
n=39 Participants
|
85 Participants
n=41 Participants
|
175 Participants
n=35 Participants
|
|
Region of Enrollment
Israel
|
36 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
77 Participants
n=35 Participants
|
|
Average number of migraines attacks per month
|
5.2 Attacks per month
STANDARD_DEVIATION 1.95 • n=39 Participants
|
5.3 Attacks per month
STANDARD_DEVIATION 1.90 • n=41 Participants
|
5.3 Attacks per month
STANDARD_DEVIATION 1.92 • n=35 Participants
|
|
Average number of migraine days per month
|
6.6 Days per month
STANDARD_DEVIATION 2.43 • n=39 Participants
|
6.6 Days per month
STANDARD_DEVIATION 2.41 • n=41 Participants
|
6.6 Days per month
STANDARD_DEVIATION 2.40 • n=35 Participants
|
|
Use of preventive medication
|
36 Participants
n=39 Participants
|
46 Participants
n=41 Participants
|
82 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 hours post migraine onsetThe percentage of patients reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their first treated migraine attack (excluding the "run-in test" treatment).
Outcome measures
| Measure |
Treatment of Migraine With Sham Device
n=103 Participants
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
Treatment of Migraine With Active Device
n=99 Participants
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
|---|---|---|
|
Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment
|
40 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 2 hours post migraine onsetThe percentage of patients reporting, 2 hours post-treatment, freedom from their most bothersome migraine-associated symptom (MBS) other than a headache, in their first treated migraine attack (excluding the "run-in test" treatment). MBS may be nausea, photophobia, phonophobia or allodynia - as defined by each subject at the beginning of the treatment
Outcome measures
| Measure |
Treatment of Migraine With Sham Device
n=99 Participants
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
Treatment of Migraine With Active Device
n=95 Participants
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
|---|---|---|
|
Percentage of Participants With Reduction of Most Bothersome Migraine-associated Symptom (MBS) Relief at 2 Hours Post Treatment
|
22 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 2 hours post migraine onsetPopulation: 4 participants in the active group and 4 participants in the sham group did not report their MBS level at the beginning of the treatment or at 2 hours post treatment. Thus, the active and sham groups included 95 and 99 participants, respectively
The percentage of patients reporting, 2 hours post treatment response to both the primary and the first secondary endpoints
Outcome measures
| Measure |
Treatment of Migraine With Sham Device
n=99 Participants
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
Treatment of Migraine With Active Device
n=95 Participants
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
|---|---|---|
|
Percentage of Participants With Reduced Migraine Headache AND MBS Relief at 2 Hours Post Treatment
|
15 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 2 hours post migraine onsetThe percentage of subjects reporting freedom from migraine pain at 2 hours post-treatment without medications in their first treated migraine attack
Outcome measures
| Measure |
Treatment of Migraine With Sham Device
n=103 Participants
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
Treatment of Migraine With Active Device
n=99 Participants
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
|---|---|---|
|
Percentage of Participants With Pain Disappearance at 2 Hours Post Treatment
|
19 Participants
|
37 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 14 weeksThe number of Adverse events related to the study device. Safety analyses were performed on all participants from the ITT population (126 participants in each group).
Outcome measures
| Measure |
Treatment of Migraine With Sham Device
n=126 Participants
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
Treatment of Migraine With Active Device
n=126 Participants
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
|---|---|---|
|
Number of Adverse Events Related or Unrelated to the Study Device
|
9 Adverse event
|
14 Adverse event
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 weeksThe repeatability of migraine headache reduction, as described in the primary endpoint definition, in subsequent treated attacks. Thus, this endpoint measures the % of patient responding to the primary endpoint in at least 50% of their treated attacks (excluding the run-in attack
Outcome measures
| Measure |
Treatment of Migraine With Sham Device
n=103 Participants
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
Treatment of Migraine With Active Device
n=99 Participants
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
|---|---|---|
|
Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments
|
38.1 percentage of participants
Interval 31.2 to 46.6
|
51.3 percentage of participants
Interval 42.8 to 61.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 hours post treatmentPopulation: 12 participants in the active group and 14 participants in the sham group did not report their pain level at 24h post treatment for the "Test" treatment. Thus, the active and sham groups included 87and 89 participants, respectively
The proportion (%) of subjects reporting pain-free at 2 hours, and no return of any pain or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
Outcome measures
| Measure |
Treatment of Migraine With Sham Device
n=89 Participants
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
Treatment of Migraine With Active Device
n=87 Participants
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
|---|---|---|
|
Percentage of Participants With Sustained Pain-free 48 Hours With Single Use of the Device
|
6 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 hours post treatmentPopulation: 12 participants in the active group and 14 participants in the sham group did not report their pain level at 24h post treatment for the "Test" treatment. Thus, the active and sham groups included 87and 89 participants, respectively
The proportion (%) of subjects reporting treatment response 2 hours post-treatment without rescue medications, and no return to baseline level of pain at time of treatment, or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
Outcome measures
| Measure |
Treatment of Migraine With Sham Device
n=89 Participants
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
Treatment of Migraine With Active Device
n=87 Participants
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
|---|---|---|
|
Percentage of Participants With Sustained Headache Reduction for 48 Hours With Single Use of the Device
|
14 Participants
|
32 Participants
|
Adverse Events
Treatment of Migraine With Active Device
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Treatment of Migraine With Sham Device
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment of Migraine With Active Device
n=126 participants at risk
Treatment of acute migraine with an active form of Nerivio migra-1 device
Nerivio Migra-1 active device: The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
|
Treatment of Migraine With Sham Device
n=126 participants at risk
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Nerivio Migra-1 Sham device: The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Sensation of warmth
|
4.8%
6/126 • Number of events 6 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
2.4%
3/126 • Number of events 3 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
|
Nervous system disorders
Numbness of the arm
|
1.6%
2/126 • Number of events 2 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
0.00%
0/126 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
|
Nervous system disorders
Pain in the arm
|
1.6%
2/126 • Number of events 2 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
0.00%
0/126 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
|
Skin and subcutaneous tissue disorders
Redness of the skin at the treatment area
|
1.6%
2/126 • Number of events 2 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
0.79%
1/126 • Number of events 1 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
|
Product Issues
Neck and shoulder pain
|
0.00%
0/126 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
1.6%
2/126 • Number of events 2 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
|
Product Issues
Tingling
|
0.00%
0/126 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
2.4%
3/126 • Number of events 3 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
|
Nervous system disorders
Muscle spasm
|
0.79%
1/126 • Number of events 1 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
0.00%
0/126 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.79%
1/126 • Number of events 1 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
0.00%
0/126 • up to 14 weeks
The Nerivio device is a neurostimulator and it is externally applied over the body. The Nerivio is accepted as a non-significant risk (NSR) device. In addition, as the exclusion criteria for the study leave out participant with electrical implant, congenital heart failure or epilepsy, the number of high risk participants is zero.
|
Additional Information
Dr Dagan Harris. VP Clinical & Regulatory Affairs
Theranica Bio-Electronics Ltd
Phone: +972723909755
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place