|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03083860 |
|
Date of registration:
|
14/03/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
|
|
Scientific title:
|
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions. |
|
Date of first enrolment:
|
September 2017 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03083860 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Israel
| | | | | | | |
|
Contacts
|
|
Name:
|
David Yarnitzki, MD, Prof. |
|
Address:
|
|
|
Telephone:
|
972-47772605 |
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
David Yarnitzki, MD, Prof. |
|
Address:
|
|
|
Telephone:
|
972-47772605 |
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Migraine
|
|
Intervention(s)
|
|
Device: BEI
|
|
Primary Outcome(s)
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|