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

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ClinicalTrials.gov Identifier: NCT01935661
Recruitment Status : Enrolling by invitation
First Posted : September 5, 2013
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Thalassemia Brain Function (Measured by ERP Level)

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia
U.S. FDA Resources




Primary Outcome Measures :
  1. Brain function assessment evaluated by Event-related potentials (ERPs of the information stream in the brain of Thalassemia patients. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. correlation between brain function evaluated by ERP measurements and Hemosiderosis parameters like ferritin levels, Iron transferrin and Saturation. [ Time Frame: one year ]

Other Outcome Measures:
  1. correlation between pre and post transfusion status related to the Hemoglobin concentration and brain function measured by ERP. [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
60 Thalasssemia major and intermedia patients. 60 healthy controls.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935661


Locations
Israel
Haemek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Carina Levin, MD Pediatric Hematology Unit - Emek Medical Center

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01935661     History of Changes
Other Study ID Numbers: 111-12-EMC
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by HaEmek Medical Center, Israel:
Blood transfusion
Hemosiderosis
ERP

Additional relevant MeSH terms:
Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn