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

Last updated: February 5, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Data recovery from language and cognitive assessment

Clinical Study ID

NCT06817642
APHP220542
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 participationin CALAP

  • History of stroke

  • Posterior fossa stroke

Study Design

Total Participants: 570
Treatment Group(s): 1
Primary Treatment: Data recovery from language and cognitive assessment
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
December 01, 2029

Connect with a study center

  • Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor

    Créteil, 94010
    France

    Active - Recruiting

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