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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Brainmarc Ltd.
Sponsor:
Information provided by (Responsible Party):
Brainmarc Ltd.
ClinicalTrials.gov Identifier:
NCT02583581
First received: October 1, 2015
Last updated: June 15, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Migraine Device: EEG monitoring (MindWave by NeuroSky) Device: EEG monitoring (EPOC by Emotiv)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Feasibility Study for Examination the Use of Brain Prefrontal Activity Monitoring, for Early Detection of Migraine Attack

Resource links provided by NLM:


Further study details as provided by Brainmarc Ltd.:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 50
Study Start Date: October 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants diagnosed with migraine
EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv)
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.
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02583581

Contacts
Contact: Yael Rozen, Dr. 972-6660677 yael@brainmarc.com

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 35254
Contact: Yelena Granovsky, Dr.    972-4-854-2222    y_granovsky@rambam.health.gov.il   
Sponsors and Collaborators
Brainmarc Ltd.
Investigators
Principal Investigator: David Yarnitsky, MD Rambam Health Care Campus
  More Information

Responsible Party: Brainmarc Ltd.
ClinicalTrials.gov Identifier: NCT02583581     History of Changes
Other Study ID Numbers: CLD4
Study First Received: October 1, 2015
Last Updated: June 15, 2017

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2017