Characteristics of Blood- Brain Barrier Permeability in Neurological Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility Study of New MRI Protocol in Assessing Early Blood Brain Barrier Disruption (BBBD)in Related to Delay Brain Edema

NCT01830894

Intra Cerebral Hemorrhage

UNKNOWN PHASE1/PHASE2

Blood-retinal Barrier Imaging and Neuropsychiatric Sequela in Type 2 Diabetes Mellitus

NCT01107132

Type 2 Diabetes Mellitus Non-Proliferative Diabetic Retinopathy Diabetic Macular Edema

UNKNOWN

Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke

NCT03366129

Cerebrovascular Disorder Stroke Aging

COMPLETED

Microvascular Injury and Blood-brain Barrier Dysfunction as Novel Biomarkers and Targets for Treatment in Traumatic Brain Injury

NCT03139682

Traumatic Brain Injury Blood Brain Barrier Defect

COMPLETED

Dysregulated CNS Inflammation After Acute Brain Injury

NCT03287557

Traumatic Brain Injury Aneurysmal Subarachnoid Hemorrhage

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury Cerebral Infarction Cerebral Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes