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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583581
• Other study ID #: CLD4
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2015
• Last updated: June 15, 2017
• Start date: October 2015
• Est. completion date: February 2018

Study information

• Verified date: June 2017
• Source: Brainmarc Ltd.
• Contact: Yael Rozen, Dr.
• Phone: 972-6660677
• Email: yael[@]brainmarc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Brainmarc Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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