Traumatic Brain Injury Clinical Trial
Official title:
Open Study on the Validation of Non-invasive Absolute Intracranial Pressure Monitoring in Patients After Traumatic Brain Injury and Subarachnoid Hemorrhage
Primary objective of this study is to assess the accuracy and precision of intracranial
pressure (ICP) measurement in patients after traumatic brain injury and subarachnoid
hemorrhage when using simultaneous, non-invasive measurement compared to standard, invasive,
measurement.
Secondary objective: is to assess the correlation of intracranial pressure (ICP) measurement
in patients after traumatic brain injury and subarachnoid hemorrhage between simultaneous,
non-invasive measurement and standard, invasive,measurement
Currently, ICP (Intracranial Pressure) can be measured only using invasive techniques. In a
previous (pilot study) a non-invasive technique for measurement of ICP was investigated
(based on simultaneously measuring of ophthalmic artery (OA) blood flow parameters in the
intracranial (IOA) and extracranial (EOA) segments of the OA with two-depth transcranial
Doppler (TCD)). Based on the good results of the previous study, the study should be repeated
in order to further validate the new method in more patients and to obtain additional insight
with more measurements.
This single centre, observational comparative study shall investigate a new non-invasive ICP
absolute value measurement method in patients presenting with TBI, ICH, or secondary edema
after stroke or Subarachnoid Hemorrhage (SAH) compared to current standard invasive ICP
monitoring methods.Suitable patients are to be recruited soonest after their referral or
admission to the Department of Neurosurgery at the Kantonsspital Aarau. Measurement will be
done either at the surgical Intensive Care Unit, Stroke Unit ("SIC") or Neurosurgical
Intermediate Care Unit ("NCW"). All measurements will be performed on intubated and sedated
patients with invasive ICP Monitoring trough an intraparenchymatous or intraventricular
probe. In the same patient, several measurements will be allowed daily.
The non-invasive technique for measurement of ICP is based on simultaneously measuring of an
ophthalmic artery (OA) blood flow parameters in the intracranial (IOA) and extracranial (EOA)
segments of the OA with two-depth transorbital Doppler (TCD) measurements including
mechanical head frame for fixation of ultrasonic transducer on the closed eye lid. ICP
pressure will be measured non-invasively by using Vittamed 205® device. This device has CE
marking since July 2014.
It is planned to recruit 25 patients and to collect 69 independent paired non-invasive and
invasive ICP measurements during a 24 months period after study approval.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
| Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
| Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
| Terminated |
NCT03698747 -
Myelin Imaging in Concussed High School Football Players
|
||
| Recruiting |
NCT05130658 -
Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training
|
N/A | |
| Recruiting |
NCT04560946 -
Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI
|
N/A | |
| Completed |
NCT05160194 -
Gaining Real-Life Skills Over the Web
|
N/A | |
| Recruiting |
NCT02059941 -
Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines
|
N/A | |
| Recruiting |
NCT03940443 -
Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
|
||
| Recruiting |
NCT03937947 -
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
|
||
| Completed |
NCT04465019 -
Exoskeleton Rehabilitation on TBI
|
||
| Recruiting |
NCT04530955 -
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
|
N/A | |
| Recruiting |
NCT03899532 -
Remote Ischemic Conditioning in Traumatic Brain Injury
|
N/A | |
| Suspended |
NCT04244058 -
Changes in Glutamatergic Neurotransmission of Severe TBI Patients
|
Early Phase 1 | |
| Completed |
NCT03307070 -
Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury
|
N/A | |
| Recruiting |
NCT04274777 -
The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
|
||
| Withdrawn |
NCT04199130 -
Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI
|
N/A | |
| Withdrawn |
NCT05062148 -
Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery
|
N/A | |
| Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 |