NCT04244240Completed
Links Between Cognitive Functions and Clinical, Biological and Neuroradiological Outcomes in Adults With Sickle Cell Disease.
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.
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 19 (actual)
- First submitted
- 23 Jan 2020
- Start date
- 13 Oct 2020
- Primary completion date
- 5 Apr 2024
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Sickle cell disease
- NCT number
- NCT04244240
What you commit to
- Study type: Observational
- Participants enrolled: 19
- From 13 Oct 2020 to the primary completion date, 5 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient not compliant in the management of his disease
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Edouard Herriot Coordinator of this site? Confirm its status | Bron | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.