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Evaluation 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
Brainmarc Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Migraine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

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

First Posted
March 14, 2017
Last Updated
June 15, 2017
Sponsor
Brainmarc Ltd.
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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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