Back to resultsEvaluation of Use of Brain Activity Monitoring for Prediction of Migraine Attacks
Primary Purpose
Migraine
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
EEG monitoring (MindWave by NeuroSky)
EEG monitoring (EPOC by Emotiv)
Sponsored by
About this trial
This is an interventional diagnostic trial for Migraine
Eligibility 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.
Sites / Locations
- Rambam Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants diagnosed with migraine
Arm Description
EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv)
Outcomes
Primary Outcome Measures
Measurements of brain electrical signal in Micro volt.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02583581
Brief Title
Evaluation of Use of Brain Activity Monitoring for Prediction of Migraine Attacks
Official Title
A Feasibility Study for Examination the Use of Brain Prefrontal Activity Monitoring, for Early Detection of Migraine Attack
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brainmarc Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants diagnosed with migraine
Arm Type
Experimental
Arm Description
EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv)
Intervention Type
Device
Intervention Name(s)
EEG monitoring (MindWave by NeuroSky)
Intervention Description
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
Intervention Name(s)
EEG monitoring (EPOC by Emotiv)
Intervention Description
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 Measure Information:
Title
Measurements of brain electrical signal in Micro volt.
Description
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).
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Rozen, Dr.
Phone
972-6660677
Email
yael@brainmarc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Yarnitsky, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
35254
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yelena Granovsky, Dr.
Phone
972-4-854-2222
Email
y_granovsky@rambam.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Use of Brain Activity Monitoring for Prediction of Migraine Attacks
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