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This is a retrospective controlled survey study to assess the safety of treating migraine with Nerivio during pregnancy and 3 months postpartum. The study will compare migraine and pregnancy-related health and baby health between women with migraine who treated migraine attacks during pregnancy with Nerivio (Nerivio group), to women with migraine who did not treat migraine attacks during pregnancy with Nerivio (control group). Nerivio group participants will be recruited from Theranica's user base. Control group participants will be recruited by health care providers, including headache specialists and OBGYNs (study co-investigators). The study is based on an e-Survey including an e-eligibility questionnaire, an e-ICF ande-Questionnaire. Participants will be compensated for their time.
This is a retrospective controlled survey study to assess the safety of treating migraine with Nerivio during pregnancy and 3 months postpartum. The study will compare migraine and pregnancy-related health and baby health between women with migraine who treated migraine attacks during pregnancy with Nerivio (Nerivio group), to women with migraine who did not treat migraine attacks during pregnancy with Nerivio (control group).
Study group: Study group participants will be recruited from Nerivio's user base. An invitation message will be sent via in-app notification and/or email to all Nerivio users who are (1) female, AND (2) between 18 and 42 years of age as of November 1st, 2019 - March 31st, 2021. Users who meet these criteria will be invited to fill in a screening and eligibility questionnaire. If they meet the eligibility criteria, they will be offered the opportunity to participate in the study. Participants will complete and sign an electronic informed consent form. Following consent, participants will be asked to complete the questionnaire. Once complete, participants will be compensated for their time.
Control group: Control group participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period. Patients interested in participating will be directed to the same screening and eligibility questionnaire and will follow the same study design.
Endpoints focus on the health of the mother and the baby, during pregnancy and three months postpartum.
Primary endpoint:
Demonstrate that the study group is not different than the control group in regard to gestational age at delivery (measured in pregnancy weeks).
Secondary endpoints:
Demonstrate that the study group is not different from the control group in:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postpartum females with migraine who used Nerivio during their pregnancy | Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database |
| |
| Postpartum females with migraine who used other migraine therapy during their pregnancy | Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerivio | Device | Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age at Delivery | The mean number of gestational age at delivery in both study groups (measured in pregnancy days). | Retrospective Data for up to 42 weeks, collected over 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Birth Weight | The mean weight of the newborn children at the time of delivery in both study groups (measured in Pounds). | Retrospective Data for up to 42 weeks, collected over 2 months |
| Miscarriage Rate |
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Inclusion Criteria:
Exclusion Criteria:
Postpartum women
Post pregnant women between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy."
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| Name | Affiliation | Role |
|---|---|---|
| Alit Stark Inbar, PhD | Theranica USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego (UCSD) | San Diego | California | 92037 | United States | ||
| Theranica USA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37335242 | Result | Peretz A, Stark-Inbar A, Harris D, Tamir S, Shmuely S, Ironi A, Halpern A, Chuang L, Riggins N. Safety of remote electrical neuromodulation for acute migraine treatment in pregnant women: A retrospective controlled survey-study. Headache. 2023 Jul-Aug;63(7):968-970. doi: 10.1111/head.14586. Epub 2023 Jun 19. No abstract available. |
| Label | URL |
|---|---|
| Pubmed reference | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database Nerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application |
| FG001 | Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period Migraine Relief: Any drug for treatment of migraine relief |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database Nerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Gestational Age at Delivery | The mean number of gestational age at delivery in both study groups (measured in pregnancy days). | Posted | Mean | Standard Deviation | Gestational days | Retrospective Data for up to 42 weeks, collected over 2 months |
|
Retrospective Data for up to 42 weeks, collected over 2 months
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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 | Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy | Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database Nerivio: Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Dagan Harris, VP Clinical and Regulatory Affairs | Theranica | +972542220121 | daganh@theranica.com |
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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 | Jun 1, 2022 | Aug 18, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Migraine Relief | Drug | Any drug for treatment of migraine relief |
|
|
The percent of miscarriage in both study groups
| Retrospective Data for up to 42 weeks, collected over 2 months |
| Preterm Birth Rate | The percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups | Retrospective Data for up to 42 weeks, collected over 2 months |
| Birth Deficits Rate | The percent of birth deficits in both study groups | Retrospective Data for up to 42 weeks, collected over 2 months |
| Still Births Rate | The percent of Still birth in both study groups | Retrospective Data for up to 42 weeks, collected over 2 months |
| Developmental Milestones Rate Following 3 Months Postnatal | The rate of developmental milestones between the study groups. Develpment milestones includes motor skills, hearing, vision and communication (e.g bringing hands to their mouth, and recognizing familiar voices and faces) | Retrospective Data for up to 55 weeks, collected over 2 months |
| Migraine Patterns | The proportion of patients that visits the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period in both study groups | Retrospective Data for up to 55 weeks, collected over 2 months |
| Montclair |
| New Jersey |
| 07042 |
| United States |
| BG001 | Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period Migraine Relief: Any drug for treatment of migraine relief |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | The body Mass Index of the participant prior pregnancy | Mean | Standard Deviation | Kg/m^2 |
|
| Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy |
Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period Migraine Relief: Any drug for treatment of migraine relief |
|
|
|
| Secondary | Birth Weight | The mean weight of the newborn children at the time of delivery in both study groups (measured in Pounds). | Posted | Mean | Standard Deviation | Weight (pounds) | Retrospective Data for up to 42 weeks, collected over 2 months |
|
|
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| Secondary | Miscarriage Rate | The percent of miscarriage in both study groups | Posted | Count of Participants | Participants | Retrospective Data for up to 42 weeks, collected over 2 months |
|
|
|
| Secondary | Preterm Birth Rate | The percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups | Posted | Count of Participants | Participants | Retrospective Data for up to 42 weeks, collected over 2 months |
|
|
|
| Secondary | Birth Deficits Rate | The percent of birth deficits in both study groups | Posted | Count of Participants | Participants | Retrospective Data for up to 42 weeks, collected over 2 months |
|
|
|
| Secondary | Still Births Rate | The percent of Still birth in both study groups | Posted | Count of Participants | Participants | Retrospective Data for up to 42 weeks, collected over 2 months |
|
|
|
| Secondary | Developmental Milestones Rate Following 3 Months Postnatal | The rate of developmental milestones between the study groups. Develpment milestones includes motor skills, hearing, vision and communication (e.g bringing hands to their mouth, and recognizing familiar voices and faces) | Posted | Count of Participants | Participants | Retrospective Data for up to 55 weeks, collected over 2 months |
|
|
|
| Secondary | Migraine Patterns | The proportion of patients that visits the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period in both study groups | Posted | Count of Participants | Participants | Retrospective Data for up to 55 weeks, collected over 2 months |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy | Postpartum patients with migraine who did not used Nerivio prior and during their pregnancy, and at least 3 months postpartum. Participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period Migraine Relief: Any drug for treatment of migraine relief | 0 | 81 | 0 | 81 | 0 | 81 |
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| D009422 | Nervous System Diseases |