Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date January 23, 2020
First Posted Date January 28, 2020
Last Update Posted Date March 24, 2022
Actual Study Start Date October 13, 2020
Estimated Primary Completion Date October 13, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2020)		 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Links Between Cognitive Functions and Clinical, Biological and Neuroradiological Outcomes in Adults With Sickle Cell Disease.
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.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with sickle cell disease and cognitive complaint
Condition
  • Sickle Cell Disease
  • Drepanocytosis
Intervention 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.
Study Groups/Cohorts Sickle cell disease patient
Adults with sickle cell disease (homozygous SS or heterozygous SC, Sβ0 or Sβ+) with cognitive complaint.
Intervention: Behavioral: BEARNI Tool
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 27, 2020)		 50
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 13, 2024
Estimated Primary Completion Date October 13, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04244240
Other Study ID Numbers 69HCL19_0753
2019-A02709-48 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Hospices Civils de Lyon
Original Responsible Party Same as current
Current Study Sponsor Hospices Civils de Lyon
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date March 2022