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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
Grant Number	5U54HL070587-04

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

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Study Publications

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Mental Health (1)

Mental Health (1)

Data Element	Variables
ASCQ-Me Emotional Impact
ASCQ-Me Social Functioning
Brief Resiliency Scale
NeuroQOL Fatigue
NIH Toolbox Loneliness
Pearlin Enhanced Self-Efficacy Scale
Profile of Mood States (POMS)	DEPRESS
PROMIS Anger
PROMIS Anxiety
PROMIS Depression
PROMIS Emotional Distress- Depression
PROMIS Emotional Support
PROMIS Fatigue
PROMIS Global Mental Health
PROMIS Satisfaction with Participation in Discretionary Social Activities

Neurodevelopment (48)

Neurodevelopment (48)

Data Element	Variables
Achenbach Child Behavior Checklist (CBCL)
Bayley Scale of Infant and Toddler Development
Behavior Rating Inventory of Executive Function (BRIEF)
California Verbal Learning Test	ACCPCT1 ACCPCT2 BIASSTN CORSTN5 CORSTN6 CORSTN7 CORSTN8 DISCSTN FPSTN6 HITSTN5 INTSTN3 LDRZSCR REPSTN4 SDRZSCR SEMSTN SERSTN SUBSTN TDRSTN TLSTSTN
Children's Memory Scale
Connor's Continuous Performance Test II
Delis-Kaplan Executive Function System (D-KEFS)	CWCOMPS CWCON1S CWCON2S CWCON3S CWCON4S CWCONTA CWCONTB CWCONTC TMCOMPS TMCON1S TMCON2S TMCON3S TMCON4S TMCON5S TMCONTA TMCONTB TMCONTC TMCONTD TMCONTE TQSCLA TQSCLB TQSCLC TTACHVS VFCN3AS VFCN3BS VFCON1S VFCON2S VFCSCF4 VFLFCF4
NeuroQOL Cognitive Function
Peabody Picture Vocabulary Test (PPVT)

Neuropsychological (285)

Neuropsychological (285)

Data Element	Variables
Adaptive Behavior Assessment System-II
Adverse Childhood Experience Questionnaire (ACE-Q)
Beery Developmental Test of Visual-Motor Integration
Benton Tactile Form Perception Test
Mini Mental Status Examination (MMSE)	MMSETOT
Oral Verbal Fluency Test
PROMIS Cognitive Function
Purdue Pegboard (SPA version)
Test of Everyday Attention (TEA)	ECD ECR L MS1 MS2 TS TSC VE1 VE2
Vineland Adaptive Behavior Summary
Wechsler Intelligence Scales	ASSDY CONFINT DIFFP DIFFQ DIFFR DIFFS DIFFT DIFFU DIFFV FRQDIFA FRQDIFB FRQDIFC FRQDIFD FRQDIFE FRQDIFF FRQDIFG FRQDIFH FRQDIFI FRQDIFJ FRQDIFK FRQDIFL FRQDIFM FRQDIFN FRQDIFP FRQDIFQ FRQDIFR FRQDIFS FRQDIFT FRQDIFU FRQDIFV FSIQCON FSIQIND FSIQIND FSIQPCT FSIQSUM FULLSS LEVEL1 LEVEL2 MDIFFA MDIFFB MDIFFC MDIFFD MDIFFE MDIFFF MDIFFG MDIFFH MDIFFI MDIFFJ MDIFFK MDIFFL MDIFFM MDIFFN MEANA MEANB MEANC MEAND MEANE MEANF MEANG MEANH MEANI MEANJ MEANK MEANL MEANM MEANN PERFA PERFC PERFE PERFG PERFJ PERFL PERFN PERFS PIQ_P PIQCON PIQIND PIQIND PIQIND_LE85 PIQPCT PIQSUM POA POE POG POI_Q POI_S POI_U POICON POIIND POIIND POIPCT POISUM POS PSC PSI_S PSI_T PSI_V PSICON PSIIND PSIIND PSIPCT PSISUM PSL PSS PSSQ1 PSSQ10 PSSQ2 PSSQ3 PSSQ4 PSSQ5 PSSQ6 PSSQ7 PSSQ8 PSSQ9 PSSSUMSCORE RAWA RAWB RAWC RAWD RAWE RAWF RAWG RAWH RAWI RAWJ RAWK RAWL RAWM RAWN SCALEA1 SCALEA2 SCALEB1 SCALEB2 SCALEC1 SCALEC2 SCALED1 SCALED2 SCALEE1 SCALEE2 SCALEF1 SCALEF2 SCALEG1 SCALEG2 SCALEH1 SCALEH2 SCALEI1 SCALEI2 SCALEJ1 SCALEJ2 SCALEK1 SCALEK2 SCALEL1 SCALEL2 SCALEM1 SCALEM2 SCALEN1 SCALEN2 STATA STATB STATC STATD STATE STATF STATG STATH STATI STATJ STATK STATL STATM STATN STATP STATQ STATR STATS STATT STATU STATV STRWEKA STRWEKB STRWEKC STRWEKD STRWEKE STRWEKF STRWEKG STRWEKH STRWEKI STRWEKJ STRWEKK STRWEKL STRWEKM STRWEKN VCB VCD VCI VCI_Q VCI_R VCI_T VCICON VCIIND VCIIND VCIPCT VCISUM VCS VERBB VERBD VERBF VERBH VERBI VERBK VERBM VERBS VIQ_P VIQCON VIQIND VIQIND VIQPCT VIQSUM WAISPIQIND1 WMF WMH WMH WMI_R WMI_U WMI_V WMICON WMIIND WMIIND WMIPCT WMISUM WMM WMS
Wechsler Memory Scale	ADINDEX AIINDEX ARDINDX GMINDEX IMINDEX VDINDEX VIINDEX
Wisconsin Card Sorting Test	P21TSCR10 P21TSCR10NUM P21TSCR12 P21TSCR12NUM P21TSCR3 P21TSCR3NUM P21TSCR4 P21TSCR4NUM P21TSCR5 P21TSCR5NUM P21TSCR6 P21TSCR6NUM P21TSCR7 P21TSCR7NUM P21TSCR8 P21TSCR8NUM P21TSCR9 P21TSCR9NUM P23TSCR10 P23TSCR10NUM P23TSCR12 P23TSCR12NUM P23TSCR3 P23TSCR3NUM P23TSCR4 P23TSCR4NUM P23TSCR5 P23TSCR5NUM P23TSCR6 P23TSCR6NUM P23TSCR7 P23TSCR7NUM P23TSCR8 P23TSCR8NUM P23TSCR9 P23TSCR9NUM
Woodcock-Johnson Revised, Tests of Achievement
Woodcock-Johnson, Revised, Tests of Cognitive Ability

Pain (0)

Pain (0)

Physical Function (0)

Physical Function (0)

Psychosocial (0)

Psychosocial (0)

Quality of Care (0)

Quality of Care (0)

Quality of Life (13)

Quality of Life (13)

Data Element	Variables
ASCQ-Me SCD Medical History Checklist
ASCQ-Me Sexual Health
Child Health Questionnaire (CHQ)
Ladder of Life
Pediatric Quality of Life Inventory Child Report (ages 13-18)
Pediatric Quality of Life Inventory Child Report (ages 8-12)
Pediatric Quality of Life Inventory Parent Report for Child (ages 13-18)
Pediatric Quality of Life Inventory Parent Report for Child (ages 8-12)
PROMIS Global Health
PROMIS Global Physical Health
PROMIS Self-Efficacy for Managing Medications and Treatment
SF-36 Health Survey	P21AGG_MENT P21AGG_PHYS P23AGG_MENT P23AGG_PHYS SFQ1 SFQ10 SFQ11A SFQ11B SFQ11C SFQ11D SFQ6 SFQ7 SFQ8

Sleep (0)

Sleep (0)

Technology Support (0)

Technology Support (0)

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