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Links Between Cognitive Functions and Clinical, Biological and Neuroradiological Outcomes in Adults With Sickle Cell Disease. (Drépa-COG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04244240
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Sickle Cell Disease Drepanocytosis Behavioral: BEARNI Tool

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : October 13, 2020
Estimated Primary Completion Date : October 13, 2024
Estimated Study Completion Date : October 13, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Sickle cell disease patient
Adults with sickle cell disease (homozygous SS or heterozygous SC, Sβ0 or Sβ+) with cognitive complaint.
 Behavioral: BEARNI Tool

BEARNI is brief screening tool initially validated for Alcohol-related neuropsychological impairments (Ritz et al., 2015). BEARNI tool detect impairment in visuospatial abilities, executive functions, verbal episodic memory, and verbal working memory.

The score of the test could be expressed as a global score, and also as subscores corresponding to each cognitive subtest. Normative data are available.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with sickle cell disease and cognitive complaint
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
Contacts and Locations
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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): NCT04244240


Contacts
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Contact: Antoine GARNIER-CRUSSARD 04 72 43 21 27 ext +33 antoine.garnier-crussard@chu-lyon.fr
Contact: Romain FORT, MD, PhD 04 72 11 91 85 ext +33 romain.fort@chu-lyon.fr

Locations
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France
Hôpital Edouard Herriot Recruiting
Bron, France, 69437
Contact: Antoine GARNIER-CRUSSARD    04 72 43 21 27 ext +33    antoine.garnier-crussard@chu-lyon.fr   
Contact: Romain FORT, MD, PhD    04 72 11 91 85 ext +33    romain.fort@chu-lyon.fr   
Principal Investigator: Antoine GARNIER-CRUSSARD         
Sub-Investigator: Romain FORT, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04244240    
Other Study ID Numbers: 69HCL19_0753
2019-A02709-48 ( Other Identifier: ID-RCB )
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Sickle Cell Disease
Drepanocytosis
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Sickle Cell Trait
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn