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Characteristics of Blood- Brain Barrier Permeability in Neurological Patients

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ClinicalTrials.gov Identifier: NCT00419874
Recruitment Status : Unknown
Verified November 2006 by Soroka University Medical Center.
Recruitment status was:  Recruiting
First Posted : January 9, 2007
Last Update Posted : January 9, 2007
Information provided by:
Soroka University Medical Center

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.

Condition or disease
Traumatic Brain Injury Cerebral Infarction Cerebral Hemorrhage

Detailed Description:

Traumatic brain injury (TBI) is one of the most common traumatic events, occurring in approximately 200 per 100,000, 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 (e.g. 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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Blood- Brain Barrier Permeability in Neurological Patients: Anatomical, Neurophysiological, and Clinical Characteristics

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • One week following:

    • Traumatic Brain Injury
    • Cerebro- Vascular Accident
  • Subsequent brain CT showed cerebral cortex injury.

Exclusion Criteria:

  • A known ailment of the central nervous system.
  • Use of medications or illicit drugs that significantly affect the central nervous system.
  • tourist or temporary residents not available for follow-up.
  • For MRI examinations: heart pacemaker, metal implants, or metal shrapnel.

Information from the National Library of Medicine

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): NCT00419874

Contact: Alon Friedman, MD/PhD alonf@bgu.ac.il

Soroka University Medical Center Recruiting
Beer Sheva, Israel
Contact: Alon Friedman, MD/PhD       alonf@bgu.ac.il   
Principal Investigator: Alon Friedman, MD/PhD         
Sponsors and Collaborators
Soroka University Medical Center
Principal Investigator: Alon Friedman, MD/PhD Soroka University Medical Center
Principal Investigator: Ilan Shelef, MD Soroka University Medical Center

ClinicalTrials.gov Identifier: NCT00419874     History of Changes
Other Study ID Numbers: SOR444206CTIL
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: January 9, 2007
Last Verified: November 2006

Keywords provided by Soroka University Medical Center:
Blood-brain barrier
Post traumatic epilepsy

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Cerebral Infarction
Cerebral Hemorrhage
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Intracranial Hemorrhages