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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke Patients
• Intervention / Treatment: Other: Data recovery from language and cognitive assessment

• Study Type: Observational
• Enrollment (Estimated): 570

Contacts and Locations

• Study Contact: Name: Anne-Catherine BACHOUD-LEVI, MD, PhD; Phone Number: 0033 01 49 81 43 01; Email: anne-catherine.bachoud-levi@aphp.fr
• Study Contact Backup: Name: Tiffany MONNIER, MD, PhD; Phone Number: 0033 01 45 17 84 86; Email: tiffany.monnier@aphp.fr

Study Locations

• France
  • Créteil, France, 94010
    • Recruiting
    • Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor
    • Contact: Anne-Catherine BACHOUD-LEVI, MD,PHD; Phone Number: +33 01 49 81 23 10; Email: anne-catherine.bachoud-levi@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Stroke patients (hemispheric stroke, ischemic or hemorrhagic).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Language recovery prediction with Core Assessment of Language Processing score	the objective is to predict from stroke patient's language performance in the acute phase, his or her language performance in the late phase	18 months after stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving CALAP recovery prediction using MRI data	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).	18 months after stroke
Improving CALAP recovery prediction using neuropsychological data	Improvement of the predictive value of the CALAP score in the acute phase using neuropsychological assessment data collected in the acute phase.	18 months after stroke
Cognitive recovery prediction with Core Assessment of Language Processing score	The objective is to predict cognitive abilities at the chronic phase based on language performance in the acute phase	18 months after stroke
Improving CALAP recovery prediction using language rehabilitation data	The objective is to assess whether language rehabilitation modifies the predictive power of the language abilities assessed with the CALAP	18 months after stroke

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Aphasia; Language abilities; Cognitive abilities; Prediction of function recovery
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: APHP220542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No