ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02583581
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Device: EEG monitoring (MindWave by NeuroSky) Device: EEG monitoring (EPOC by Emotiv) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : October 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Brainmarc Ltd.
ClinicalTrials.gov Identifier: NCT02583581     History of Changes
Other Study ID Numbers: CLD4
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

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