Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.

Not Applicable

• Conditions: Migraine
• Interventions: Device: BEI

• Registration Number: NCT03083860
• Lead Sponsor: Brainmarc Ltd.

Brief Summary

Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-20
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16
• Study Start: 2017-09
• Primary Completion: 2018-04
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosed with migraine by a neurologist.
• Male or Female, aged 18 -50 years.
• Having 3-10 migraine attacks per month.
• Able and willing to comply with all study requirements.
• Having Android based smartphone

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 eardrum impairment.
• Having migraine attacks occurring only during the menstruation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	BEI	15-45 participants will be monitored for 4-6 weeks, using the App in a Closed version followed by 4-6 weeks, using the App in an Open version (A version of the app the generates recommendations of ADL interventions) , with feedback based on diary information and BEI; followed by 4-6 weeks using the App in an Open version, with feedback based on diary information only.
Arm II	BEI	15-45 participants will be monitored for 4-6 weeks, using the App in a Closed version followed by 4-6 weeks, using the App in an Open version with feedback based on diary information only followed by 4-6 weeks; followed by 4-6 weeks using the App in an Open version, with feedback based on diary information and BEI. Note the difference between Arm I and Arm II is the order of use of BEI in addition to the diary feedback.

Primary Outcome Measures

Name	Time	Method
Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app.	12 months	significant difference between interictal days and treictal days

Trial Locations

Locations (1)

Rambam MC; 🇮🇱 Haifa, Israel