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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03083860
• Other study ID #: CLD10
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2017
• Last updated: June 15, 2017
• Start date: September 2017
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Brainmarc Ltd.
• Contact: David Yarnitzki, MD, Prof.
• Phone: 972-47772605
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: April 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.

• 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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• BEI
BrainMARC Ltd. has demonstrated in recent years the ability to extract effective attention markers from averaged ERP waves sampled with a single EEG channel (two electrodes). In addition, BrainMARC has developed a template matching method to extract the attention-related markers at the single-trial level. An index (termed Brain Engagement Index - BEI) can then be generated from a 1-minute, single-channel sample.

Locations

Country	Name	City	State
Israel	Rambam MC	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Brainmarc Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app.	significant difference between interictal days and treictal days	12 months