MigraineNCT03083860
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
A study testing BEI in people with Migraine, run by Brainmarc Ltd. at 1 site in Israel.
Trial summary
Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Migraine
- What is being tested?
- BEI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2017to Dec 2018
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with migraine by a neurologist.
- Male or Female, aged 18 -50 years.
- Having 3-10 migraine attacks per month.
- Able and willing to comply with all study requirements.
- Having Android based smartphone
Who cannot join
- Diagnosed with chronic pain, neurological or psychiatric disorders.
- Current or past use of anti-depressants.
- A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
- History of seizures.
- Head injury with consciousness loss in the last three months.
- Diagnosed as ADHD and/or use of Ritalin.
- Hearing disorder and/or known eardrum impairment.
- Having migraine attacks occurring only during the menstruation.
Trial locations and contacts
1 site in 1 country.
David Yarnitzki, MD, Prof. contact
About this study
Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions.
- Conditions
- Migraine
- Being tested
- BEI
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEIDevice
BrainMARC Ltd. has demonstrated in recent years the ability to extract effective attention markers from averaged ERP waves sampled with a single EEG channel (two electrodes). In addition, BrainMARC has developed a template matching method to extract the attention-related markers at the single-trial level. An index (termed Brain Engagement Index - BEI) can then be generated from a 1-minute, single-channel sample.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Other | 15-45 participants will be monitored for 4-6 weeks, using the App in a Closed version followed by 4-6 weeks, using the App in an Open version (A version of the app the generates recommendations of ADL interventions) , with feedback based on diary information and BEI; followed by 4-6 weeks using the App in an Open version, with feedback based on diary information only. Receives: Device: BEI |
| Arm II | Other | 15-45 participants will be monitored for 4-6 weeks, using the App in a Closed version followed by 4-6 weeks, using the App in an Open version with feedback based on diary information only followed by 4-6 weeks; followed by 4-6 weeks using the App in an Open version, with feedback based on diary information and BEI. Note the difference between Arm I and Arm II is the order of use of BEI in addition to the diary feedback. Receives: Device: BEI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app.
significant difference between interictal days and treictal days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startSep 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups of 15-45 patients will be recruited in parallel and monitored for 4-6 weeks, than they will be followed for 4-6 weeks. They will receive feedback based on diary information and EEG.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainmarc Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083860
- Sponsor's protocol ID
- CLD10
- Status last verified
- Jun 2017
- First submitted
- 14 Mar 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
- ClinicalTrials.gov ID
- NCT03083860
- Acronym / sponsor ID
- CLD10
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brainmarc Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Mar 2017 (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.
Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups of 15-45 patients will be recruited in parallel and monitored for 4-6 weeks, than they will be followed for 4-6 weeks. They will receive feedback based on diary information and EEG.
| Arm | Type | Receives |
|---|---|---|
| Arm I | Other | Device: BEI15-45 participants will be monitored for 4-6 weeks, using the App in a Closed version followed by 4-6 weeks, using the App in an Open version (A version of the app the generates recommendations of ADL interventions) , with feedback based on diary information and BEI; followed by 4-6 weeks using the App in an Open version, with feedback based on diary information only. |
| Arm II | Other | Device: BEI15-45 participants will be monitored for 4-6 weeks, using the App in a Closed version followed by 4-6 weeks, using the App in an Open version with feedback based on diary information only followed by 4-6 weeks; followed by 4-6 weeks using the App in an Open version, with feedback based on diary information and BEI. Note the difference between Arm I and Arm II is the order of use of BEI in addition to the diary feedback. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with migraine by a neurologist.
- Male or Female, aged 18 -50 years.
- Having 3-10 migraine attacks per month.
- Able and willing to comply with all study requirements.
- Having Android based smartphone
Key exclusion criteria (8 listed)
- Diagnosed with chronic pain, neurological or psychiatric disorders.
- Current or past use of anti-depressants.
- A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
- History of seizures.
- Head injury with consciousness loss in the last three months.
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 |
|---|---|---|
| BEIBrainMARC Ltd. has demonstrated in recent years the ability to extract effective attention markers from averaged ERP waves sampled with a single EEG channel (two electrodes). In addition, BrainMARC has developed a template matching method to extract the attention-related markers at the single-trial level. An index (termed Brain Engagement Index - BEI) can then be generated from a 1-minute, single-channel sample. | Device | Arm I, Arm II |
Primary outcome
Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app.
Time frame: 12 months
significant difference between interictal days and treictal days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
David Yarnitzki, MD, Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEI in people with Migraine, run by Brainmarc Ltd. at 1 site in Israel.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Jun 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Yarnitzki, MD, Prof. (972-47772605), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app. (time frame: 12 months). 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 16 Jun 2017.