Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419874
Status:
UNKNOWN
Last Update Posted:
2007-01-09
First Post:
2007-01-07
Brief Title:
Characteristics of Blood- Brain Barrier Permeability in Neurological Patients
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
Blood- Brain Barrier Permeability in Neurological Patients Anatomical Neurophysiological and Clinical Characteristics
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main goal of the present study is to challenge the hypothesis that blood- brain barrier disruption following brain injury increases the risk for long-term disability development of brain dysfunction epileptic seizures and neuroanatomical alterations
Detailed Description:
Traumatic brain injury TBI is one of the most common traumatic events occurring in approximately 200 per 100000 and is a known risk factor for later development of epileptic seizures This occurs in up to 17 of TBI patients and accounts for approximately 20 of symptomatic epilepsies Annegers JF et al 1998 Typically post-traumatic epilepsy PTE develops or several weeks but even years after the event PTE is often chronic and poorly controlled pharmacologically Although several factors have been attributed to an increased risk of developing PTE eg severity of trauma type of brain injury time to the appearance of first seizure the mechanisms underlying it remain unknown Similar to TBI ischemic injuries most frequently occurring in the elderly population are the main cause of new onset epilepsy in this age group It is still not known what are the risk factors and mechanisms underlying post-ischemic epilepsy
Under normal conditions the central nervous system is protected by the operation of the blood- brain barrier BBB Following brain injury either traumatic or ischemic the BBB is known to disrupt leading to focal edema and altered extracellular composition We have recently established methods for quantitative evaluation of the integrity of the BBB using magnetic resonance imaging MRI brain scans Using these methods we are able to identify BBB disruption in patients suffering from various pathologies Tomkins O et al 2001 Avivi E et al 2004 Such altered permeability may last up to years following the acute event and was found to correlate to areas of abnormal neurological function Korn A et al 2005
In recent work using an animal model we have shown that following focal disruption of the BBB a focus of epileptiform activity is generated within several days Such pathological activity remains for several weeks long after the BBB has retained its former function Seiffert E et al 2004 Iven S et al 2006 Furthermore this condition may later lead to anatomical alterations as seen by brain MRI scans as well as in histological sections Such animals further suffer from functional deterioration and neuronal degeneration in the disrupted region Tomkins O et al 2006
In this work we will test the hypothesis that BBB disruption following brain injury increases the risk for long-term disability development of brain dysfunction epileptic seizures and neuroanatomical alterations For that we will combine a prospective and retrospective study in patients following cerebral cortical injury traumatic hemorrhagic or ischemic Clinical functional and anatomical measures will be obtained in addition to BBB permeability measures
Under normal conditions the central nervous system is protected by the operation of the blood- brain barrier BBB Following brain injury either traumatic or ischemic the BBB is known to disrupt leading to focal edema and altered extracellular composition We have recently established methods for quantitative evaluation of the integrity of the BBB using magnetic resonance imaging MRI brain scans Using these methods we are able to identify BBB disruption in patients suffering from various pathologies Tomkins O et al 2001 Avivi E et al 2004 Such altered permeability may last up to years following the acute event and was found to correlate to areas of abnormal neurological function Korn A et al 2005
In recent work using an animal model we have shown that following focal disruption of the BBB a focus of epileptiform activity is generated within several days Such pathological activity remains for several weeks long after the BBB has retained its former function Seiffert E et al 2004 Iven S et al 2006 Furthermore this condition may later lead to anatomical alterations as seen by brain MRI scans as well as in histological sections Such animals further suffer from functional deterioration and neuronal degeneration in the disrupted region Tomkins O et al 2006
In this work we will test the hypothesis that BBB disruption following brain injury increases the risk for long-term disability development of brain dysfunction epileptic seizures and neuroanatomical alterations For that we will combine a prospective and retrospective study in patients following cerebral cortical injury traumatic hemorrhagic or ischemic Clinical functional and anatomical measures will be obtained in addition to BBB permeability measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None