Evaluation of Use of Brain Activity Monitoring for Prediction of Migraine Attacks

Not Applicable

• Conditions: Migraine
• Interventions: Device: EEG monitoring (MindWave by NeuroSky); Device: EEG monitoring (EPOC by Emotiv)

• Registration Number: NCT02583581
• Lead Sponsor: Brainmarc Ltd.

Brief Summary

This study evaluates the use of brain activity monitoring for prediction of migraine attacks in an expected time scale of 12-48 hours prior to the migraine attack.

Detailed Description

The study will be conducted in one are. Participants diagnosed with migraine, will be evaluated for their EEG characteristics as well as daily migraine related clinical and general status. Participants' monitoring will be conducted for 20 times for a duration of one month.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16
• Primary Completion: 2018-01
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosed with migraine by a neurologist.
• Male or Female, aged 18 -50 years.
• Able and willing to comply with all study requirements.
• Having 3-10 migraine attacks per month.

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 ear drum impairment.
• Having migraine attacks occurring only during the menstruation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants diagnosed with migraine	EEG monitoring (MindWave by NeuroSky)	EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv)
Participants diagnosed with migraine	EEG monitoring (EPOC by Emotiv)	EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv)

Primary Outcome Measures

Name	Time	Method
Measurements of brain electrical signal in Micro volt.	1 months	Measurements of brain electrical signal in Micro volt will be quantified by an algorithm and correlated to reported migraine cycle (as reported by migraine patients in questionnaires).

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel