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

NCT03083860 | Unknown

• 1 other identifier: CLD10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm I

OTHER

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.

Device: BEI

Arm II

OTHER

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.

Device: BEI

Interventions

BEI DEVICE

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.

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Brainmarc Ltd.: lead

Study Sites (1)

Rambam MC

Haifa, Israel

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

David Yarnitzki, MD, Prof.

CONTACT

972-47772605

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 groups of 15-45 patients will be recruited in parallel and monitored for 4-6 weeks, than they will be followed for 4-6 weeks. They will receive feedback based on diary information and EEG.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: September 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

IL (1)