Working...

Study Detail

Study ID 1026
Name Comprehensive Sickle Cell Centers' (CSCC) -Neuropsych
Contact Email EVichinsky@mail.cho.org
Acronym CSCC-Neuropsych
Period 2004 - 2008
Design Observational cohort study
Study PI Elliott Vichinsky
Institution RTI International
URL https://clinicaltrials.gov/ct2/show/NCT00528801
CTGovID https://clinicaltrials.gov/ct2/show/NCT00528801
Funding Agency NHLBI
Overview In Phase I, approximately 156 subjects will participate in a cross-sectional studyconsisting of screening questionnaires, a neuropsychological testing battery, and MRI testing. InPhase II, a subset of approximately 30 participants will be asked to participate in a transfusionintervention. Half will be randomized to undergo a chronic transfusion regimen for six months, and theother half will be treated with standard care alone, guided by their disease symptoms.
Focus Areas 1. To determine the extent of neurocognitive dysfunction in neurologicallyasymptomatic adult patients with sickle cell disease.
2. To determine the association between neurocognitive dysfunction and imagingabnormalities.
Outcomes 1. Wechsler Adult Intelligence Scale (WAIS)-III Performance IQ [ Time Frame: Within 2 months of signing informed consent.]
2. Participants With Brain Lacunae as Measured by Clinical MRI [ Time Frame: Within 2 months of informed consent ]
3. Volume of Total Cortical Gray Matter as Measured by Volumetric MRI. [ Time Frame: Within 2 months of informed consent ]
Data Location RTI International
Biospecimen Available Blood; Urine;
Data Consent Consent includes Certificate of Confidentiality. Deidentified data may be used for continuing research.
Biospecimen Consent NA
Contact Consent NA
Genomic Data No
Age Range 21 - 55
No. Participants 212
Inclusion Criteria 1. Adult between the ages of 21 and 55
2. African descent
3. Proficient/fluent in English
4. Hemoglobin electrophoresis confirming hemoglobin SS or SB0 (%A <= 15)
5. Hemoglobin <= 10 g/dL
6. Capable of giving informed consent for the protocol
Exclusion Criteria 1. Overt stroke
2. Previous evidence of an abnormal MRI or CT other than small peri-ventricular or watershed lesions
3. History of head injury that resulted in neurological symptoms or medical visit
4. Abnormal neurologic exam with focal findings
5. Mini-Mental Status Examination (MMSE) score of < 20
6. Profile of Mood States (POMS) score on the Depression-Dejection Subscale suggestive of a clinical depression (score > 40)
7. Alcohol consumption exceeding 14 drinks/week if female, 21 drinks/week if male
8. Drug abuse, defined as using non-prescribed medication
9. History of claustrophobia and/or presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body
10. Pregnancy
11. Baseline blood pressure > 140/90 on two repeated measurements. A second measurement is needed only if the first is > 140/90
12. History of uncontrolled hypertension
13. Any chronic disorder that may result in neurocognitive or brain dysfunction that is not secondary to SCD.
14. Currently on Procrit or related drug that stimulates red blood cell production
Study Documentation
  Select All
Forms
  Select All

Study Publications
Back to Study List