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

Brainmarc

Status: Unknown

Conditions: Migraine

Treatments: Device: BEI

Study type: Interventional

Funder types: Industry

Identifiers

NCT03083860

CLD10

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm I

Other group

Description:

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.

Treatment:

Device: BEI

Arm II

Other group

Description:

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.

Treatment:

Device: BEI