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

Thalassemia Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01935661
• Other study ID #: 111-12-EMC
• Status: Active, not recruiting
• Start date: September 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• beta-Thalassemia
• Brain Function (Measured by ERP Level)
• Thalassemia

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	correlation between pre and post transfusion status related to the Hemoglobin concentration and brain function measured by ERP.		one year
Primary	Brain function assessment evaluated by Event-related potentials (ERPs of the information stream in the brain of Thalassemia patients.		one year
Secondary	correlation between brain function evaluated by ERP measurements and Hemosiderosis parameters like ferritin levels, Iron transferrin and Saturation.		one year