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

NCT06817642 | Recruiting

• 1 other identifier: APHP220542
• Study Type: observational
• Target: 570
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Stroke Patients

Keywords

Stroke; Aphasia; Language abilities; Cognitive abilities; Prediction of function recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Improving CALAP recovery prediction using MRI data

  18 months after stroke

• Improving CALAP recovery prediction using neuropsychological data

  18 months after stroke

• Cognitive recovery prediction with Core Assessment of Language Processing score

  18 months after stroke

• Improving CALAP recovery prediction using language rehabilitation data

  18 months after stroke

Interventions

Data recovery from language and cognitive assessment OTHER

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stroke patients (hemispheric stroke, ischemic or hemorrhagic).

You may qualify if:

• 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
• ≤ NIHSS score ≤21 or if NIHSS score \< 4, LAST score \[0-13\]
• Non-opposition to participation in tests

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Stroke; Aphasia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anne-Catherine BACHOUD-LEVI, MD, PhD

CONTACT

01 49 81 43 01; anne-catherine.bachoud-levi@aphp.fr

Tiffany MONNIER, MD, PhD

CONTACT

01 45 17 84 86; tiffany.monnier@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: February 10, 2025
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)