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Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.

Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03083860
Enrollment
100
Registered
2017-03-20
Start date
2017-09-30
Completion date
2018-12-31
Last updated
2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief summary

Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions.

Interventions

DEVICEBEI

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.

Sponsors

Brainmarc Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app.12 monthssignificant difference between interictal days and treictal days

Countries

Israel

Contacts

Primary ContactDavid Yarnitzki, MD, Prof.
972-47772605

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026