Back to resultsEvaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
Primary Purpose
Migraine
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
BEI
Sponsored by
About this trial
This is an interventional device feasibility trial for Migraine
Eligibility Criteria
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.
Sites / Locations
- Rambam MC
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Arm I
Arm II
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03083860
Brief Title
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
Official Title
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brainmarc Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Other
Arm 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.
Arm Title
Arm II
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
BEI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app.
Description
significant difference between interictal days and treictal days
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Yarnitzki, MD, Prof.
Phone
972-47772605
Facility Information:
Facility Name
Rambam MC
City
Haifa
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Yarnitzki, MD, Prof.
Phone
972-47772605
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
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