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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02130219 |
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Date of registration:
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20/03/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Value of Noninvasive Intracranial Pressure Measurement
Braincare |
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Scientific title:
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Scientific Research and Development of Innovative Evidence Based Non-invasive Brain Diagnostic and Monitoring Solutions for Neurological and Traumatic Brain Injury Patients |
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Date of first enrolment:
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June 2013 |
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Target sample size:
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45 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02130219 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Lithuania
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Contacts
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Name:
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Kestutis Petrikonis |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lithuanian University of Health Sciences |
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Name:
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Kestutis Petrikonis, MD, PhD |
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Address:
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Telephone:
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00370326747 |
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Email:
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kestutispetrikonis@yahoo.com |
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Affiliation:
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Name:
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Kestutis Petrikonis, MD,PhD |
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Address:
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Telephone:
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Email:
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kestutispetrikonis@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic daily headache with suspected idiopathic intracranial hypertension
- Diagnosed of suspected multiple sclerosis (MS)
- Intracranial hemorrhage/ stroke
Exclusion Criteria:
- Patient not able to understand information about the trial
- Uncooperative patient
- Intracranial hemorrhage volume <20 or >40ml
- Stroke area larger than 1/3 of the middle cerebral artery
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Intracranial Hypertension
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Intervention(s)
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Device: Brain MRI/CT
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Procedure: Lumbar puncture and cerebrospinal fluid pressure measurement
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Device: Non-invasive intracranial pressure measurement
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Primary Outcome(s)
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Number of participants with the results of noninvasive intracranial pressure measurement (with Vittamed 205 aICP meter) within clinically acceptable 4 mm Hg difference from invasively measured CSF pressure.
[Time Frame: Simultaneous noninvasive ICP and CSF pressure measurements. All measurements will be collected within 20 months until 31 December 2014.]
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Secondary ID(s)
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CH-3-SMM-01/06
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BE-2-26
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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