Examining Cognitive Function and Brain Abnormalities in Adults With Sickle Cell Disease
Completed
Conditions studied: Anemia, Sickle Cell
In brief
Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes and may lead to organ failure. Preliminary studies have shown that adults with SCD may have brain abnormalities that contribute to problems with cognitive functioning, including attention and memory difficulties. This study will use brain magnetic resonance imaging (MRI) and neuropsychological testing to examine the differences in cognitive functioning in adults with SCD and adults without SCD. 212 subjects participated in this cross-sectional study consisting of screening questionnaires, a neuropsychological testing battery, and MRI testing. Enrollment into this study ended in May 2008.
Key facts
- Study ID
- NCT00528801
- Run by
- UCSF Benioff Children's Hospital Oakland
- People needed
- 212
- Starts
- 2004-12-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2017-03-21
Who can join
Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Individuals who meet all of the following criteria are eligible for enrollment as cases into the study:
- Adult between the ages of 21 and 55
- African descent
- Proficient/fluent in English
- Hemoglobin electrophoresis confirming hemoglobin SS or SB0 (%A <= 15)
- Hemoglobin <= 10 g/dL
- Capable of giving informed consent for the protocol
- Individuals who meet all of the following criteria are eligible for enrollment as community controls into the study:
- Adult between the ages of 21 and 55
- African descent
- Proficient/fluent in English
- Capable of giving informed consent for the protocol
You may not qualify if…
- Individuals who meet any of the following criteria are disqualified from enrollment in the case group of the study:
- Overt stroke
- Previous evidence of an abnormal MRI or CT other than small peri-ventricular or watershed lesions
- History of head injury that resulted in neurological symptoms or medical visit
- Abnormal neurologic exam with focal findings
- Mini-Mental Status Examination (MMSE) score of < 20
- Profile of Mood States (POMS) score on the Depression-Dejection Subscale suggestive of a clinical depression (score > 40)
- Alcohol consumption exceeding 14 drinks/week if female, 21 drinks/week if male
- Drug abuse, defined as using non-prescribed medication
- History of claustrophobia and/or presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
- Pregnancy
- Baseline blood pressure > 140/90 on two repeated measurements. A second measurement is needed only if the first is > 140/90
- History of uncontrolled hypertension
- Any chronic disorder that may result in neurocognitive or brain dysfunction that is not secondary to SCD including:
- Inflammatory arterial disorders (lupus, polyarteritis)
- History of cancer requiring chemotherapy and/or radiation
- Untreated hyperlipidemia
- Diabetes
- Ongoing active infection such as HIV, tuberculosis, sarcoidosis
- History of chronic transfusion
- Chronic renal failure/Dialysis
- Chronic lung disease characterized by need for oxygen
- Morbid obesity (weight >115 kg)
- Heart disease: history of congestive heart failure, history of severe coronary artery disease characterized by angioplasty or surgery, or history of angina
- Active hepatitis or liver failure
Where it is running
- University of Southern California — Los Angeles, California, United States
- Children's Hospital & Research Center at Oakland — Oakland, California, United States
- Memorial Cancer Institute — Hollywood, Florida, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- Medical College of Georgia — Augusta, Georgia, United States
- Boston Medical Center — Boston, Massachusetts, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States
- Children's Medical Center at Dallas — Dallas, Texas, United States
- University of Texas Medical Branch — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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