An interventional study of 3T (Tesla) Magnetic Resonance Imaging (MRI) in Von Willebrand Disease, Type 2B, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by University Hospital, Caen · Not applicable, Interventional, and Basic science
The working hypothesis is that patients with Von Willebrand Disease-type 2B may have neurological symptoms due to the chronic formation of platelets/Von Willebrand Factor aggregates. Interestingly, several patients present nonspecific neurological symptoms (nystagmus, headaches, memory disorder, ...) which may be associated with cerebral microangiopathy and chronic microvessel inflammation secondary to Von Willebrand Disease-type 2B due to chronic exposure to Von Willebrand Factor-platelets complexes.
Investigator will use an extensive series of neuropsychological tests that cover virtually all cognitive domains. A measurement of global cognitive function will be assessed by the Mini Mental State Examination (MMSE). The verbal memory function will be assessed by the Rey Auditory Verbal Learning Test (RAVLT). Visuospatial memory will be administered by the Rey's Complex Figure Test (RCFT). To evaluate speed of mental processes, Stroop test (three subtasks), the Paper and Pencil Memory Scanning Task (four subtasks), the Symbol-Digit Substitution Task will be used. To evaluate attention, the verbal series attention test (VSAT) will be used. To register subjective cognitive failures investigator will administer the Cognitive failures questionnaire (CFQ). The neurological evaluation will be completed with 3T (Tesla) Magnetic Resonance Imaging (MRI) with different MRI sequences including T1 3D SPACE, FLAIR 3D , 3D SWI (Susceptibility weighted imaging) and 2D EPI (Echo Planar Imaging) to address the presence of cerebral small vessel disease. The presence of each of the four MRI markers for cerebral small vessel disease (white matter hyperintensities, lacunes, cerebral microbleeds and perivascular spaces will be addressed.
63 studies on the registry are indexed under Von Willebrand Diseases; 4 are open to participants now.
This study's planned enrollment of 5 is below the median of 26 across 28 interventional studies indexed under Von Willebrand Diseases.
Browse Von Willebrand Diseases studies →University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
evaluation of patients using 3T (Tesla) Magnetic Resonance Imaging (MRI) and series of neuropsychological tests that cover virtually all cognitive domains.
Procedure: 3T (Tesla) Magnetic Resonance Imaging (MRI)
Neurological evaluation using MRI and neuropsychological tests
Also known as: Series of neuropsychological tests that cover virtually all cognitive domains
Rate of cerebral lesions in patients with type 2B disease
Analysis of MRI sequences and % of patients with cerebral lesions
Time frame: at the inclusion
Global cognitive function evaluation
Mini Mental State Examination (MMSE) will be used
Time frame: at the inclusion
Verbal memory function evaluation
Rey Auditory Verbal Learning Test (RAVLT) will be used
Time frame: at the inclusion
Visuospatial memory evaluation
Rey's Complex Figure Test (RCFT) will be used
Time frame: at the inclusion
Speed of mental processes evaluation
Stroop test will be used
Time frame: at the inclusion
Attention evaluation
Verbal series attention test (VSAT) will be used
Time frame: at the inclusion
Subjective cognitive failures evaluation
Cognitive failures questionnaire (CFQ) will be used
Time frame: at the inclusion
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Caen