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

NCT ID: NCT02583581

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Participants diagnosed with migraine

EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv)

Group Type EXPERIMENTAL

EEG monitoring (MindWave by NeuroSky)

Intervention Type DEVICE

EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.

EEG monitoring (EPOC by Emotiv)

Intervention Type DEVICE

EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.

Interventions

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EEG monitoring (MindWave by NeuroSky)

EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.

Intervention Type DEVICE

EEG monitoring (EPOC by Emotiv)

EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brainmarc Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Yarnitsky, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yael Rozen, Dr.

Role: CONTACT

972-6660677

Facility Contacts

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Yelena Granovsky, Dr.

Role: primary

972-4-854-2222

Other Identifiers

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CLD4

Identifier Type: -

Identifier Source: org_study_id

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