Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
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|ClinicalTrials.gov Identifier: NCT02773901|
Recruitment Status : Unknown
Verified December 2016 by HeadSense Medical.
Recruitment status was: Recruiting
First Posted : May 16, 2016
Last Update Posted : December 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Hypertension||Device: HS-1000||Not Applicable|
In this study we will prospectively collect relevant clinical data on 60 neurological patients, who are being referred for an elective lumbar puncture (eg. suspected multiple sclerosis, raised intracranial hypertension, etc). Each enrolled patient will be monitored in parallel to the lumbar puncture with the HeadSense ICP monitor. Subjects who meet the study inclusion and exclusion criteria will be enrolled in the study.
Step 1: 10 minute measurement of HeadSense monitor. Once the patient is inclined with his upper body 30 degrees to the bed the pressure values, the clinical procedure can begin. The device must be preset in a continuous monitoring mode. The continuous monitoring allows a loop of measurements for an unlimited time in a rate of four measurements per minute.
Step 2: 10 minute measurement of HeadSense monitor in supine position.
Step 3: Patient will be placed in a left lateral position. The lumbar puncture will be done and CSF pressure will be measured following standard procedures.
Step 4: 10 minute measurement of HeadSense monitor in supine position.
Lumbar puncture and HeadSense measurement will be done by two different doctors and they will not share measurement values during the procedure.
After the study the patient's ears will be examined for internal ear infection or irritation that might be caused by the ear buds. Patient adverse events will be documented on the case report forms in case they occurred and the family or advocate of the patient will be informed. In case of clinical relevant adverse events appropriate clinical action will be taken.
As the procedure does not affect the patient management, there is no need to provide any specific medical care related to the trial. Patients will receive the relevant clinical care related to their clinical management, without any consideration to their participation in the trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: HS-1000 recording
ICP monitoring will be done with the HS-1000 to compare to CSF measurement from lumbar puncture (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals last 10 minutes.
- Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards [ Time Frame: 10 minutes ]
- Incidence of Adverse events (AEs) [ Time Frame: 48 hours from the end of monitoring with the HS-1000 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773901
|Contact: Thomas Swansonfirstname.lastname@example.org|
|Contact: Dana Hromyakemail@example.com|
|Contact: Henrik Schytz, MD 2876 1824 firstname.lastname@example.org|
|Principal Investigator: Henrik Schytz, MD|
|Asklepios Hospitals Schildautal||Recruiting|
|Contact: Mark Obermann, MD email@example.com|
|Principal Investigator: Mark Obermann, MD|
|Contact: Guus Schoonman, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Guus Schoonman, MD, PhD|
|Principal Investigator:||Henrik Schytz, MD||Rigshospitalet-Glostrup|