Characteristics of Blood- Brain Barrier Permeability in Neurological Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Soroka University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00419874
First received: January 7, 2007
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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
Traumatic Brain Injury
Cerebral Infarction
Cerebral Hemorrhage

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Blood- Brain Barrier Permeability in Neurological Patients: Anatomical, Neurophysiological, and Clinical Characteristics

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Estimated Enrollment: 100
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.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419874

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

Locations
Israel
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
Investigators
Principal Investigator: Alon Friedman, MD/PhD Soroka University Medical Center
Principal Investigator: Ilan Shelef, MD Soroka University Medical Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00419874     History of Changes
Other Study ID Numbers: SOR444206CTIL
Study First Received: January 7, 2007
Last Updated: January 7, 2007
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 23, 2014