A Case Control Study to Evaluate the Cognitive and Brain Function of β-thalassemia Patients.

• Conditions: Brain Function (Measured by ERP Level); Thalassemia

• Registration Number: NCT01935661
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-07
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Thalassemia major and intermedia patients older than 6 years treated at Emek Medical Center Afula Israel.
• healthy controls matched for age and ethnicity.

Exclusion Criteria

• patients suffering from acute diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain function assessment evaluated by Event-related potentials (ERPs of the information stream in the brain of Thalassemia patients.	one year

Secondary Outcome Measures

Name	Time	Method
correlation between brain function evaluated by ERP measurements and Hemosiderosis parameters like ferritin levels, Iron transferrin and Saturation.	one year

Trial Locations

Locations (1)

Haemek Medical Center; 🇮🇱 Afula, Israel