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

June 15, 2017 updated by: Brainmarc Ltd.

A Feasibility Study for Examination the Use of Brain Prefrontal Activity Monitoring, for Early Detection of Migraine Attack

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants diagnosed with migraine
EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv)
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements of brain electrical signal in Micro volt.
Time Frame: 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).
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brainmarc Ltd.

Investigators

  • Principal Investigator: David Yarnitsky, MD, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLD4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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