A Case Control Study to Evaluate the Cognitive and Brain Function of β-thalassemia Patients.
|ClinicalTrials.gov Identifier: NCT01935661|
Recruitment Status : Enrolling by invitation
First Posted : September 5, 2013
Last Update Posted : August 10, 2017
β-thalassemia syndromes are a group of hereditary disorders characterized by a genetic deficiency in the synthesis of beta-globin chains.
In recent studies done in β-thalassemia major patients abnormal iron deposition was evident using MRI in brain structures, cortex, putamen, and caudate nucleus . In most of the cases the neurological involvement is subclinical. Cognitive functioning was evaluated in beta thalassemia major, compared with healthy controls, using a neuropsychological battery including tests of abstract reasoning, attention, executive functions, language, constructional/visuospatial skills, and memory. Patients with beta thalassemia major, in particular those showing signs of hemosiderosis, had significantly impaired function in all neuropsychological tests. There was no relationship between cognitive performances and signs of deferoxamine toxicity, deferoxamine dosage, and levels of hemoglobin and ferritin. Event-related potentials (ERPs) are one of the most informative and dynamic methods of monitoring the information stream in the living brain. ERPs are linked in time with a physical or mental event, and are typically extracted from the scalp-recorded electroencephalogram (EEG) by means of signal averaging.
ERPs have been used in the assessment of cognitive function in several disorders, including anemia and iron deficiency anemia. However, literature regarding cognitive function and ERP activity in thalassemia patients is extremely limited, especially in adults.
The purpose of this study is to evaluate the cognitive and brain function in a group of 60 thalassemia patients and compare the results to healthy controls.
|Condition or disease|
|Thalassemia Brain Function (Measured by ERP Level)|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||A Case Control Study to Evaluate the Cognitive and Brain Function of β-thalassemia Patients in EMEK MEDICAL CENTER Compare to Healthy Controls.|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2018|
- Brain function assessment evaluated by Event-related potentials (ERPs of the information stream in the brain of Thalassemia patients. [ Time Frame: one year ]
- correlation between brain function evaluated by ERP measurements and Hemosiderosis parameters like ferritin levels, Iron transferrin and Saturation. [ Time Frame: one year ]
- correlation between pre and post transfusion status related to the Hemoglobin concentration and brain function measured by ERP. [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935661
|Haemek Medical Center|
|Principal Investigator:||Carina Levin, MD||Pediatric Hematology Unit - Emek Medical Center|