Migraine in ChildrenNCT06180577
A Survey Study to Assess the Accessibility of the Nerivio Device At School
An observational study of Migraine in Children, run by Theranica at 1 site in United States.
Trial summary
This is a retrospective survey-study to assess the accessibility, preference, and frequency of adolescents using Nerivio by itself, in combination with pharmacological medications, or not at all, in the school setting. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Migraine in Children
- What is being tested?
- Nerivio
- Type of treatment
- Medical device
- How many people
- 332 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with migraine who used Nerivio at least once
Who may be able to join
- Age ≤18 years old at registration to the Nerivio app
- Treated with Nerivio at least once (≥30 minutes/treatment).
- Attended elementary, middle, junior high, or high school, while first prescribed Nerivio
- Must obtain parent/legal guardian consent form prior to signing the assent form by the adolescent and engaging in study survey.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Survey Study to Assess the Accessibility, Preference, and Frequency of Adolescents Using Nerivio in School Setting
This is a retrospective survey-study to assess the accessibility, preference, and frequency of adolescents using Nerivio by itself, in combination with pharmacological medications, or not at all, in the school setting. The study population is prescribed Nerivio users, under the age of 18 years old, who have used the Nerivio device at least once. The study will be conducted electronically, and will include eligibility questions, an electronic informed consent form signed by the parent/legal guardian (e-ICF), an assent form signed by the adolescent patient (e-Assent), and an e-survey relating to the management of headaches due to migraine attacks. Participants will be recruited from Nerivio's userbase and will be compensated for their participation.
Read the detailed description
This is a retrospective survey-study to assess the accessibility, preference, and frequency of adolescents using Nerivio by itself, in combination with pharmacological medications, or not at all, in the school setting. The study population is prescribed Nerivio users, under the age of 18 years old, who have used the Nerivio device at least once.
Study group: Participants will be recruited from Nerivio's user database. An invitation message will be sent via emails and/or in-app notifications to Nerivio users who are (1) under the age of 18 years old, and (2) treated with Nerivio at least once. Adolescents who meet these criteria will be invited to answer a screening questionnaire verifying eligibility.
Adolescents who are found eligible will be offered the opportunity to participate in the study. If they are willing, they will first be directed to an Informed Consent Form (e-ICF) to be signed by the participant's parent/legal guardian. A copy of the completed form will be automatically sent to the parent/legal guardian upon completion. If the parent/legal guardian consents via the e-ICF to his/her child's participation, an electronic assent form will follow and must be signed by the adolescent patient. A copy of the assent form will be automatically sent to the parents and the adolescent patient. Once both electronic consent forms are signed, the adolescent patient will be enrolled in the study and will be directed to the study survey.
Primary outcome measures:
Percent of adolescents' who prefer treating headaches due to migraine when they are at school with Nerivio alone, relative to other options (combination, pharmaceutical, not treating while in school).
Secondary outcome measures:
- - Distribution of barriers to adolescents who report the necessity to treat their headaches due to migraine while at school, including the need to leave class for treatment, lack of availability of treatments while at school, and time delay to treat headaches.
- - Distribution of treatments used by adolescents at school to treat migraine headaches prior to being prescribed Nerivio (specific pharmaceutical agents, or not treating at all) reflecting convergence to using Nerivio at school.
- Conditions
- Migraine in Children
- Being tested
- Nerivio
- Keywords
- Migraine, Nerivio, Headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerivioDevice
Nerivio is a prescribed Remote Electrical Neuromodulation (REN) device for treatment of migraine
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Nerivio Users | Adolescent with migraine who used Nerivio at least once Receives: Device: Nerivio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerivio usage at school
Percent of adolescents who prefer treating headaches due to migraine when they are at school with Nerivio alone, relative to other options (combination, pharmaceutical, not treating while in school).
Measured: 1 year
Secondary outcomes (2)
Limitations to migraine treatment at school
Distribution of barriers to adolescents who report the necessity to treat their headaches due to migraine while at school, including need to leave class for treatment, lack of availability of treatments while at school, time delay to treat headaches.
Measured: 1 year
Types of migraine treatments during school
Distribution of treatments used by adolescents at school to treat migraine headaches prior to being prescribed Nerivio (specific pharmaceutical agents, or not treating at all) reflecting convergence to using Nerivio at school.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Feb 2024
- Primary completion1 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alit Stark Inbar, PhD, Study director, Theranica Bio-Electronics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180577
- Sponsor's protocol ID
- RWE007
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Survey Study to Assess the Accessibility, Preference, and Frequency of Adolescents Using Nerivio in School Setting
- ClinicalTrials.gov ID
- NCT06180577
- Acronym / sponsor ID
- RWE007
- Conditions
- Migraine in Children
- Keywords
- Migraine, Nerivio, Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- TheranicaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective survey-study to assess the accessibility, preference, and frequency of adolescents using Nerivio by itself, in combination with pharmacological medications, or not at all, in the school setting. The study population is prescribed Nerivio users, under the age of 18 years old, who have used the Nerivio device at least once. The study will be conducted electronically, and will include eligibility questions, an electronic informed consent form signed by the parent/legal guardian (e-ICF), an assent form signed by the adolescent patient (e-Assent), and an e-survey relating to the management of headaches due to migraine attacks. Participants will be recruited from Nerivio's userbase and will be compensated for their participation.
Detailed description
This is a retrospective survey-study to assess the accessibility, preference, and frequency of adolescents using Nerivio by itself, in combination with pharmacological medications, or not at all, in the school setting. The study population is prescribed Nerivio users, under the age of 18 years old, who have used the Nerivio device at least once.
Study group: Participants will be recruited from Nerivio's user database. An invitation message will be sent via emails and/or in-app notifications to Nerivio users who are (1) under the age of 18 years old, and (2) treated with Nerivio at least once. Adolescents who meet these criteria will be invited to answer a screening questionnaire verifying eligibility.
Adolescents who are found eligible will be offered the opportunity to participate in the study. If they are willing, they will first be directed to an Informed Consent Form (e-ICF) to be signed by the participant's parent/legal guardian. A copy of the completed form will be automatically sent to the parent/legal guardian upon completion. If the parent/legal guardian consents via the e-ICF to his/her child's participation, an electronic assent form will follow and must be signed by the adolescent patient. A copy of the assent form will be automatically sent to the parents and the adolescent patient. Once both electronic consent forms are signed, the adolescent patient will be enrolled in the study and will be directed to the study survey.
Primary outcome measures:
Percent of adolescents' who prefer treating headaches due to migraine when they are at school with Nerivio alone, relative to other options (combination, pharmaceutical, not treating while in school).
Secondary outcome measures:
- - Distribution of barriers to adolescents who report the necessity to treat their headaches due to migraine while at school, including the need to leave class for treatment, lack of availability of treatments while at school, and time delay to treat headaches.
- - Distribution of treatments used by adolescents at school to treat migraine headaches prior to being prescribed Nerivio (specific pharmaceutical agents, or not treating at all) reflecting convergence to using Nerivio at school.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Nerivio Users | – | Device: NerivioAdolescent with migraine who used Nerivio at least once |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with migraine who used Nerivio at least once
Key inclusion criteria (4 listed)
- Age ≤18 years old at registration to the Nerivio app
- Treated with Nerivio at least once (≥30 minutes/treatment).
- Attended elementary, middle, junior high, or high school, while first prescribed Nerivio
- Must obtain parent/legal guardian consent form prior to signing the assent form by the adolescent and engaging in study survey.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NerivioNerivio is a prescribed Remote Electrical Neuromodulation (REN) device for treatment of migraine | Device | Adolescent Nerivio Users |
Primary outcome
Nerivio usage at school
Time frame: 1 year
Percent of adolescents who prefer treating headaches due to migraine when they are at school with Nerivio alone, relative to other options (combination, pharmaceutical, not treating while in school).
2 secondary outcomes
Limitations to migraine treatment at school
Time frame: 1 year
Types of migraine treatments during school
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alit Stark Inbar, PhD study director
Theranica Bio-Electronics Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine in Children, run by Theranica at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerivio usage at school (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.