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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified June 2017 by Brainmarc Ltd.
Sponsor:
Information provided by (Responsible Party):
Brainmarc Ltd.
ClinicalTrials.gov Identifier:
NCT03083860
First received: March 14, 2017
Last updated: June 15, 2017
Last verified: June 2017
  Purpose
Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions.

Condition Intervention
Migraine Device: BEI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Device Feasibility
Official Title: Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.

Resource links provided by NLM:


Further study details as provided by Brainmarc Ltd.:

Primary Outcome Measures:
  • Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app. [ Time Frame: 12 months ]
    significant difference between interictal days and treictal days


Estimated Enrollment: 100
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I
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
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 II
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03083860

Contacts
Contact: David Yarnitzki, MD, Prof. 972-47772605

Locations
Israel
Rambam MC Not yet recruiting
Haifa, Israel
Contact: David Yarnitzki, MD, Prof.    972-47772605      
Sponsors and Collaborators
Brainmarc Ltd.
  More Information

Responsible Party: Brainmarc Ltd.
ClinicalTrials.gov Identifier: NCT03083860     History of Changes
Other Study ID Numbers: CLD10
Study First Received: March 14, 2017
Last Updated: June 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2017