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Clinical Trials/NCT04244240
NCT04244240
Completed
Not Applicable

Cognitive Functions in Adults with Sickle Cell Disease and Cognitive Complaints: Neuropsychological Assessment and Links to Demographic, Clinical, Biological, Neuroradiological Outcomes and Validation of a Cognitive Assessment Tool.

Hospices Civils de Lyon1 site in 1 country19 target enrollmentOctober 13, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sickle Cell Disease
Sponsor
Hospices Civils de Lyon
Enrollment
19
Locations
1
Primary Endpoint
BEARNI questionnaire
Status
Completed
Last Updated
last year

Overview

Brief Summary

Sickle cell disease (SCD) is an inherited blood disorder. Symptoms include acute and chronic complications. Due to progress in SCD care, patients with SCD are living longer than before and we focus more attention in chronic complications.

Children with SCD experience worse cognitive functions than healthy children, and fewer is known about cognitive functions in adults. Studies suggest lower cognitive performance in SCD, mostly in executive functions and processing speed, but the biological and anatomical substrates of cognitive decline are not yet well established in SCD. Often times, cognitive impairments and cerebral disorders are not diagnosed and treated in adults with SCD.

The main objective of this study is to propose a deep neuropsychological assessment in adults with SCD and cognitive complaints and to highlight links between cognitive functions and clinical, biological and neuroradiological markers. The hypothesis of this study is that cognitive functions are associated with severity of the SCD, with bood abnormalities, with MRI markers and Transcranial Doppler (TCD) markers of cerebrovascular disease. The secondary objective of this study is to validate a brief cognitive assessment tool (BEARNI tool) in adults with SCD.

This study is an observational cross-sectional study that will enroll adults with SCD and cognitive complaint.

Registry
clinicaltrials.gov
Start Date
October 13, 2020
End Date
April 5, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years old
  • Sickle cell anemia (homozygous SS or heterozygous SC, Sβ0, S/C, Sβ+)
  • In steady state (without vaso-occlusive crisis or acute chest syndrome at the time of measurements)
  • Presence of spontaneous cognitive complaint or requested by the physician.
  • Good command of the French language (native language or not)
  • No objection to participate in the study
  • Affiliated patient or beneficiary of social security scheme

Exclusion Criteria

  • Patient not compliant in the management of his disease
  • Patient participating in another interventional research protocol that may interfere with this protocol (according to investigator's judgment)
  • Language barrier
  • Pregnancy or breast feeding
  • MRI contraindication
  • Patient under guardianship , curatorship or justice
  • Inability to express non-opposition

Outcomes

Primary Outcomes

BEARNI questionnaire

Time Frame: Day 0

Cognitive performance will be evaluated by a large neuropsychological assessment. The cognitive score will be interpreted as raw scores, z-score adjusted for level of education, age, and sex, according to the tests and binarized into two categories (normal versus pathological performances)

Study Sites (1)

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