Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor
Créteil, 94010, France
Location status: Recruiting
NCT Number: NCT06817642
Introduction:
Stroke affects one person every 4 minutes in France (i.e. more than 140,000 new cases per year) resulting in cognitive and motor disorders. Aphasia is one of the most devastating cognitive disorders that persist in the late phase. However, early treatment of aphasia can improve the effects of rehabilitation.
Identifying, as early as possible, the patients most at risk of presenting persistent language disorders in the late phase would make it possible to improve their management and increase the effects of cognitive rehabilitation on their language abilities.
The aim of this project is to evaluate whether the Core Assessment of Language Processing (CALAP) assessed in the acute phase of stroke can predict language abilities in the late phase.
Hypothesis/Objective:
The primary objective is to determine whether the language abilities of patients in the acute phase of stroke can be used to predict language abilities in the late phase. Secondary objectives are to determine whether prediction can be improved with (1) brain MRI data and (2) neuropsychological assessment data. The (3) secondary objective is to determine whether cognitive abilities at the chronic phase can be predicted by language performance in the acute phase. The (4) secondary objective is to assess whether language rehabilitation modifies the predictive power of the language abilities assessed with the CALAP.
Method:
Patients will be included during their hospitalization after a brain vascular injury (acute phase, up to 21 days of hospitalization). After discharge, they will return for a post-stroke assessment between 3 and 18 months after the acute phase.
During these two visits, a clinical and neurological examination, a neuropsychological assessment and an MRI will be performed.
A prediction model (development and validation) will be used for all objectives using a linear regression model with cross validation. The entire sample consists of stroke patients.
The study is single-center and will have a total duration of 6 years with an estimated 570 patients included.
Conclusion:
Predicting the language abilities of a post-stroke patient will improve clinical management and direct patients requiring language rehabilitation to appropriate care.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Créteil, 94010, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Data recovery from language assessment: Core Assessment of LAnaguage Processing, and from neuropsychological assessment : Montreal Cognitive Assessment, Trail Making Test, Batterie Rapide d'Efficience Frontale (BREF), animal fluency, 5 words of Dubois, Ne
Time frame: 18 months after stroke
the objective is to predict from stroke patient's language performance in the acute phase, his or her language performance in the late phase
Time frame: 18 months after stroke
Improvement of the predictive value of the CALAP score in the acute phase using brain MRI data (lesion volume, lesion location, and/or percentage of disconnected fibers measured by MRI).
Time frame: 18 months after stroke
Improvement of the predictive value of the CALAP score in the acute phase using neuropsychological assessment data collected in the acute phase.
Time frame: 18 months after stroke
The objective is to predict cognitive abilities at the chronic phase based on language performance in the acute phase
Time frame: 18 months after stroke
The objective is to assess whether language rehabilitation modifies the predictive power of the language abilities assessed with the CALAP
Contact information is provided by the study sponsor or research team.
Anne-Catherine BACHOUD-LEVI, MD, PhD
CONTACT
01 49 81 43 01 ext. 0033
Tiffany MONNIER, MD, PhD
CONTACT
01 45 17 84 86 ext. 0033
Assistance Publique - Hôpitaux de Paris
Other
Acronym: PREDICT-CALAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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