Predicting Language Recovery in Acute Stroke Patients in the Neurovascular Intensive Care Unit: An Exploratory Study With the Core Assessment of Language Processing.

Recruiting

• Conditions: Stroke Patients

• Registration Number: NCT06817642
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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 final secondary objective is to determine whether the language abilities of an acute stroke patient can be used to predict his or her cognitive abilities in the late phase after stroke.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-07-05
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2029-06-30
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• Age: between 18 and 85 years old
• Inpatient in the initial phase of stroke (between 0 and 21 days after stroke)
• Hemispheric stroke, ischemic or haemorrhagic
• Ability to participate in tests
• Francophone
• 4≤ NIHSS score ≤21 or if NIHSS score < 4, LAST score [0-13]
• Non-opposition to participation in tests

Exclusion Criteria

• Severe alertness impairment incompatible with test participation, NIHSS score 1a. different from 0
• Severe overall intellectual deterioration incompatible with test participation
• Patients who may have a visual or hearing impairment incompatible with participation in CALAP
• History of stroke
• Posterior fossa stroke

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Language recovery prediction with Core Assessment of Language Processing score	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

Secondary Outcome Measures

Name	Time	Method
Improving CALAP recovery prediction using neuropsychological data	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.
Improving CALAP recovery prediction using MRI data	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).

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor; 🇫🇷 Créteil, France