NCT00419874

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2007

Completed
Last Updated

January 9, 2007

Status Verified

November 1, 2006

First QC Date

January 7, 2007

Last Update Submit

January 7, 2007

Conditions

Keywords

Blood-brain barrierPost traumatic epilepsySeizures

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

RECRUITING

Related Publications (4)

  • Tomkins O, Friedman O, Ivens S, Reiffurth C, Major S, Dreier JP, Heinemann U, Friedman A. Blood-brain barrier disruption results in delayed functional and structural alterations in the rat neocortex. Neurobiol Dis. 2007 Feb;25(2):367-77. doi: 10.1016/j.nbd.2006.10.006. Epub 2006 Dec 22.

    PMID: 17188501BACKGROUND
  • Ivens S, Kaufer D, Flores LP, Bechmann I, Zumsteg D, Tomkins O, Seiffert E, Heinemann U, Friedman A. TGF-beta receptor-mediated albumin uptake into astrocytes is involved in neocortical epileptogenesis. Brain. 2007 Feb;130(Pt 2):535-47. doi: 10.1093/brain/awl317. Epub 2006 Nov 21.

    PMID: 17121744BACKGROUND
  • Dreier JP, Jurkat-Rott K, Petzold GC, Tomkins O, Klingebiel R, Kopp UA, Lehmann-Horn F, Friedman A, Dichgans M. Opening of the blood-brain barrier preceding cortical edema in a severe attack of FHM type II. Neurology. 2005 Jun 28;64(12):2145-7. doi: 10.1212/01.WNL.0000176298.63840.99.

    PMID: 15985592BACKGROUND
  • Seiffert E, Dreier JP, Ivens S, Bechmann I, Tomkins O, Heinemann U, Friedman A. Lasting blood-brain barrier disruption induces epileptic focus in the rat somatosensory cortex. J Neurosci. 2004 Sep 8;24(36):7829-36. doi: 10.1523/JNEUROSCI.1751-04.2004.

    PMID: 15356194BACKGROUND

MeSH Terms

Conditions

Brain Injuries, TraumaticCerebral InfarctionCerebral HemorrhageEpilepsy, Post-TraumaticSeizures

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBrain InfarctionBrain IschemiaCerebrovascular DisordersStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisIntracranial HemorrhagesHemorrhageEpilepsyNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Alon Friedman, MD/PhD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR
  • Ilan Shelef, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alon Friedman, MD/PhD

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2007

First Posted

January 9, 2007

Last Updated

January 9, 2007

Record last verified: 2006-11

Locations