Evaluation of a Novel Device for Treatment of Migraine Headache
Study Details
Study Description
Brief Summary
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment.
Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. It is tolerable by patients and associated with no adverse effects.
The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere.
This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.
The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra electro stimulation device for the reduction of migraine headache during an attack of migraine with or without aura.
The study is intended for subject with 2-8 migraine episodes per month. patients will receive the device, either an active or a placebo type, and will be asked to use the device at home or in any location that they will be when the migraine starts.
The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral nervous system at onset of a migraine attack significantly reduce headache pain demonstrated by a significant difference between proportions of responders to the active treatment stimulation in comparison to proportion of responders that will use a placebo device.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Nerivio Migra is intended for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is self-applied to the upper arm. Treatments are self-administered by the user at the onset of a migraine attack. The device delivers extra cephalic transcutaneous electrical stimulation below the pain threshold to the skin of the upper arm at the onset of a migraine attack. Nerivio Migra is operated via a mobile application.
This is a prospective, randomized, double-blind, sham controlled multi-center clinical trial to test the ability of the Nerivio Migra neuromodulation device to relieve the patient's migraine pain during a migraine attack. The study will enroll up to 270 patients diagnosed with migraine with or without aura, per the inclusion and exclusion criteria. These patients will be individually and randomly assigned to either treatment group or control group. For sham control, electrical pulses of similar width and intensity, but much lower frequency compared to the active device will be administered. This sham program produces pulses that are perceivable by the user, thus maintaining the blinding, but on the other hand do not have therapeutic qualities, based on existing knowledge of parameters range of electro stimulation treatments.
- st visit - screening, enrollment and training on the application in diary mode Following successful screening, enrollment interview and signing of informed consent, participants will be provided with the Nerivio Migra application (either installed on their own smartphone, or on a smartphone provided by the study coordinator). The participants will be trained how to operate the application and report their migraine attacks in the patient diary mode, which is part of the application. The site personnel will be required to approve the training session in the CRF.
Stage 1 - Roll in phase The Roll-in is a period of 15 - 30 days in which at least two (2) and no more of eight (8) migraine attacks has been occurred. During this period, baseline information including mean frequency and severity of migraine attacks, occurrence of other headaches, presence of ICHD-3 diagnostic criteria for migraine with or without aura and use of preventive and rescue medications will be recorded.
- nd visit Following the Roll-in phase, the participants will arrive to the clinic and their compliance to the study procedures and eligibility to continue to the next phase will assessed.
Participants that will be eligible to continue to the treatment phase will undergo the following:
-
Participant will be randomized into one of the two study group (Active or Sham device) Investigational devices will be programmed in active or sham mode with a 1:1 ratio, in order to achieve the desired ratio between active and control groups sizes, stratified with by use of preventive medications.
-
Participant will be trained on the device, the application (in diary and treatment modes), the treatment procedures and the key elements critical for the success of the study:
-
Apply the Nerivio Migra as soon as possible following the onset of the migraine symptoms and NO LATER than 60 min from onset
-
Refrain from taking any rescue medication 2 hours following the start of treatment.
-
Perform the treatment for a period of at least 30 minutes (recommended treatment time is 45 minutes).
Stage 2 - Parallel arms, double- blind treatment phase. Participants will be instructed to activate the device at onset of a qualifying migraine attack and manually adjust stimulation intensity to a level within the pre-defined range, where it is well perceived but not painful. A qualifying migraine attack shall be preceded by at least 48 hours of freedom from migraine. Patients will be requested to refrain from use of rescue medications prior to and during the first two hours after treatment with the device, and if they cannot comply with this, record their use of rescue medications (migraine specific drugs or other medications or therapies that may be used to treat pain, from a pre-specified list) in the mobile application.
Via the smartphone application, each participant will be asked to rate his/her migraine pain level three times using Pain Grades Scale (0 - no pain, 1- mild pain, 2- moderate pain, 3 - severe pain): (1) upon starting the treatment, (2) two hours after start of treatment, (3) 48 hours after start of attack. At the start of each treatment, participants will be also asked to provide time elapsed from start of migraine symptoms to start of the treatment. Participants will be also asked to provide feedback regarding their use of medication (migraine specific drugs or other medications or therapies that may be used to treat pain, from a pre-specified list), presence of nausea, photophobia, phonophobia or allodynia, and treatment perception. After providing feedback at two hours after start of treatment and in case of pain recurrence, participants will be allowed to re-treat the attack using Nerivio Migra device.
Adverse events will be reported.
Stage 3 (optional, by subject request only) - Open label extended treatment:
Following the completion of double-blind stage of the study, all subjects will be offered a 2-month open label period using the active device.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: treatment of migraine with active device Treatment of acute migraine with an active form of Nerivio migra-1 device |
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.
|
| Sham Comparator: treatment of migraine with sham device Treatment of acute migraine with a sham form of the Nerivio Migra-1 device |
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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment [2 hours post migraine onset]
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).
Secondary Outcome Measures
- Percentage of Participants With Reduction of Most Bothersome Migraine-associated Symptom (MBS) Relief at 2 Hours Post Treatment [2 hours post migraine onset]
The 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
- Percentage of Participants With Reduced Migraine Headache AND MBS Relief at 2 Hours Post Treatment [2 hours post migraine onset]
The percentage of patients reporting, 2 hours post treatment response to both the primary and the first secondary endpoints
- Percentage of Participants With Pain Disappearance at 2 Hours Post Treatment [2 hours post migraine onset]
The percentage of subjects reporting freedom from migraine pain at 2 hours post-treatment without medications in their first treated migraine attack
Other Outcome Measures
- Number of Adverse Events Related or Unrelated to the Study Device [up to 14 weeks]
The 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).
- Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments [up to 6 weeks]
The 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
- Percentage of Participants With Sustained Pain-free 48 Hours With Single Use of the Device [48 hours post treatment]
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
- Percentage of Participants With Sustained Headache Reduction for 48 Hours With Single Use of the Device [48 hours post treatment]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects age 18-75 years old.
-
Subjects meet the ICHD-3 diagnostic criteria for migraine with or without aura
-
Subjects report 2-8 migraine attacks per month.
-
Stable migraine preventive medications in the last two months prior to recruitment (No change in usage or dosage).
-
Subjects must be able and willing to comply with the protocol
-
Subjects must be able and willing to provide written informed consent
Exclusion Criteria:
-
Subject has other significant pain, medical or psychologic problems that in the opinion of the investigator may confound the study assessments
-
Subject has an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
-
Subject has known uncontrolled epilepsy.
-
Any use of Cannabis including medical use.
-
Subject has >10 headache days per month.
-
Subject has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
-
Subject is participating in any other clinical study.
-
The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
-
Pregnant, or trying to get pregnant
-
Subject is experiencing a menstrually related migraine
-
Received OnabotulinumtoxinA or any botulinum toxin injections for migraine within the previous month
-
Received parenteral infusions for migraine within the previous 2 weeks.
-
Subject participated in a previous study with the Nerivio Migra 1 device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hartford Headache Center | Hartford | Connecticut | United States | 06107 |
| 2 | Mercy Hospital | Saint Louis | Missouri | United States | 63141 |
| 3 | Clinvest Research | Springfield | Missouri | United States | 65810 |
| 4 | Clinical Reseach Consortium | Las Vegas | Nevada | United States | 89119 |
| 5 | Northwell Health, Inc | New York | New York | United States | 11042 |
| 6 | Rochester Clinical Research | Rochester | New York | United States | 14609 |
| 7 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 8 | Rambam Medical Center | Haifa | Israel | ||
| 9 | wolfson Medical Center | H̀±olon | Israel | 58100 | |
| 10 | Meir Medical Center | Kfar Saba | Israel | 4428164 | |
| 11 | Belinson Medical Center | Petah Tikva | Israel | 4941492 | |
| 12 | Souraskyr Medical center - Ichilov | Tel Aviv | Israel |
Sponsors and Collaborators
- Theranica
- Rambam Health Care Campus
- Northwell Health
Investigators
- Study Director: David Yarnitsky, Prof, Rambam Medical Center, Israel
- Study Chair: Moris Levin, MD, University California Sun Francisco, USA
Study Documents (Full-Text)
More Information
Publications
None provided.- TCH003
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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 |
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Arm/Group Description | 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 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. |
| Period Title: Overall Study | ||
| STARTED | 126 | 126 |
| COMPLETED | 99 | 103 |
| NOT COMPLETED | 27 | 23 |
Baseline Characteristics
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | Total |
|---|---|---|---|
| Arm/Group Description | 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 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 of all reporting groups |
| Overall Participants | 126 | 126 | 252 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
43.8
(12.25)
|
41.6
(11.81)
|
42.7
(12.06)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
101
80.2%
|
102
81%
|
203
80.6%
|
| Male |
25
19.8%
|
24
19%
|
49
19.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
1.6%
|
0
0%
|
2
0.8%
|
| Native Hawaiian or Other Pacific Islander |
1
0.8%
|
1
0.8%
|
2
0.8%
|
| Black or African American |
10
7.9%
|
8
6.3%
|
18
7.1%
|
| White |
109
86.5%
|
112
88.9%
|
221
87.7%
|
| More than one race |
4
3.2%
|
5
4%
|
9
3.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
90
71.4%
|
85
67.5%
|
175
69.4%
|
| Israel |
36
28.6%
|
41
32.5%
|
77
30.6%
|
| Average number of migraines attacks per month (Attacks per month) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Attacks per month] |
5.2
(1.95)
|
5.3
(1.90)
|
5.3
(1.92)
|
| Average number of migraine days per month (Days per month) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Days per month] |
6.6
(2.43)
|
6.6
(2.41)
|
6.6
(2.40)
|
| Use of preventive medication (Count of Participants) | |||
| Count of Participants [Participants] |
36
28.6%
|
46
36.5%
|
82
32.5%
|
Outcome Measures
| Title | Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment |
|---|---|
| Description | 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). |
| Time Frame | 2 hours post migraine onset |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Arm/Group Description | 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 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. |
| Measure Participants | 99 | 103 |
| Count of Participants [Participants] |
66
52.4%
|
40
31.7%
|
| Title | Percentage of Participants With Reduction of Most Bothersome Migraine-associated Symptom (MBS) Relief at 2 Hours Post Treatment |
|---|---|
| Description | The 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 |
| Time Frame | 2 hours post migraine onset |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Arm/Group Description | 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 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. |
| Measure Participants | 95 | 99 |
| Count of Participants [Participants] |
44
34.9%
|
22
17.5%
|
| Title | Percentage of Participants With Reduced Migraine Headache AND MBS Relief at 2 Hours Post Treatment |
|---|---|
| Description | The percentage of patients reporting, 2 hours post treatment response to both the primary and the first secondary endpoints |
| Time Frame | 2 hours post migraine onset |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Arm/Group Description | 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 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. |
| Measure Participants | 95 | 99 |
| Count of Participants [Participants] |
38
30.2%
|
15
11.9%
|
| Title | Percentage of Participants With Pain Disappearance at 2 Hours Post Treatment |
|---|---|
| Description | The percentage of subjects reporting freedom from migraine pain at 2 hours post-treatment without medications in their first treated migraine attack |
| Time Frame | 2 hours post migraine onset |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Arm/Group Description | 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 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. |
| Measure Participants | 99 | 103 |
| Count of Participants [Participants] |
37
29.4%
|
19
15.1%
|
| Title | Number of Adverse Events Related or Unrelated to the Study Device |
|---|---|
| Description | The 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). |
| Time Frame | up to 14 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Arm/Group Description | 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 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. |
| Measure Participants | 126 | 126 |
| Number [Adverse event] |
14
|
9
|
| Title | Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments |
|---|---|
| Description | The 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 |
| Time Frame | up to 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Arm/Group Description | 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 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. |
| Measure Participants | 99 | 103 |
| Mean (95% Confidence Interval) [percentage of participants] |
51.3
40.7%
|
38.1
30.2%
|
| Title | Percentage of Participants With Sustained Pain-free 48 Hours With Single Use of the Device |
|---|---|
| Description | 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 |
| Time Frame | 48 hours post treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Arm/Group Description | 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 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. |
| Measure Participants | 87 | 89 |
| Count of Participants [Participants] |
18
14.3%
|
6
4.8%
|
| Title | Percentage of Participants With Sustained Headache Reduction for 48 Hours With Single Use of the Device |
|---|---|
| Description | 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 |
| Time Frame | 48 hours post treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device |
|---|---|---|
| Arm/Group Description | 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 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. |
| Measure Participants | 87 | 89 |
| Count of Participants [Participants] |
32
25.4%
|
14
11.1%
|
Adverse Events
| Time Frame | up to 14 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | ||
| Arm/Group Description | 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 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. | ||
All Cause Mortality |
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| Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/126 (0%) | 0/126 (0%) | ||
Serious Adverse Events |
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| Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/126 (0%) | 0/126 (0%) | ||
Other (Not Including Serious) Adverse Events |
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| Treatment of Migraine With Active Device | Treatment of Migraine With Sham Device | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/126 (11.1%) | 9/126 (7.1%) | ||
| Nervous system disorders | ||||
| Numbness of the arm | 2/126 (1.6%) | 2 | 0/126 (0%) | 0 |
| Pain in the arm | 2/126 (1.6%) | 2 | 0/126 (0%) | 0 |
| Muscle spasm | 1/126 (0.8%) | 1 | 0/126 (0%) | 0 |
| Product Issues | ||||
| Neck and shoulder pain | 0/126 (0%) | 0 | 2/126 (1.6%) | 2 |
| Tingling | 0/126 (0%) | 0 | 3/126 (2.4%) | 3 |
| Skin and subcutaneous tissue disorders | ||||
| Sensation of warmth | 6/126 (4.8%) | 6 | 3/126 (2.4%) | 3 |
| Redness of the skin at the treatment area | 2/126 (1.6%) | 2 | 1/126 (0.8%) | 1 |
| Itching | 1/126 (0.8%) | 1 | 0/126 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr Dagan Harris. VP Clinical & Regulatory Affairs |
|---|---|
| Organization | Theranica Bio-Electronics Ltd |
| Phone | +972723909755 |
| daganh@theranica.com |
- TCH003