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NCT Number: NCT06817642

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor

Créteil, 94010, France

Location status: Recruiting

Location contact

Anne-Catherine BACHOUD-LEVI, MD,PHD

CONTACT

[email protected]

01 49 81 23 10 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Language recovery prediction with Core Assessment of Language Processing score

    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

Secondary outcomes

  1. Improving CALAP recovery prediction using MRI data

    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).

  2. Improving CALAP recovery prediction using neuropsychological data

    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.

  3. Cognitive recovery prediction with Core Assessment of Language Processing score

    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

  4. Improving CALAP recovery prediction using language rehabilitation data

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Catherine BACHOUD-LEVI, MD, PhD

CONTACT

[email protected]

01 49 81 43 01 ext. 0033

Tiffany MONNIER, MD, PhD

CONTACT

[email protected]

01 45 17 84 86 ext. 0033

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PREDICT-CALAP

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Feb 10, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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