Evaluation of Use of Brain Activity Monitoring for Prediction of Migraine Attacks
A Feasibility Study for Examination the Use of Brain Prefrontal Activity Monitoring, for Early Detection of Migraine Attack
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJune 16, 2017
June 1, 2017
2.3 years
October 1, 2015
June 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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).
1 months
Study Arms (1)
Participants diagnosed with migraine
EXPERIMENTALEEG monitoring (MindWave by NeuroSky and EPOC by Emotiv)
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brainmarc Ltd.lead
Study Sites (1)
Rambam Medical Center
Haifa, 35254, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Yarnitsky, MD
Rambam Health Care Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2015
First Posted
October 22, 2015
Study Start
October 1, 2015
Primary Completion
January 1, 2018
Study Completion
February 1, 2018
Last Updated
June 16, 2017
Record last verified: 2017-06