Stroke PatientsPREDICT-CALAPNCT06817642
Predicting Language Recovery in Acute Stroke Patients in the Neurovascular Intensive Care Unit: An Exploratory Study With the Core Assessment of Language Processing.
An observational study of Stroke Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Data recovery from language and cognitive assessment
- How many people
- 570 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients (hemispheric stroke, ischemic or hemorrhagic).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne-Catherine BACHOUD-LEVI, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor
Créteil, 94010
Anne-Catherine BACHOUD-LEVI, MD,PHD, 01 49 81 23 10 ext. +33, anne-catherine.bachoud-levi@aphp.fr
About this study
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.
Read more
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
- Being tested
- Data recovery from language and cognitive assessment
- Keywords
- Stroke, Aphasia, Language abilities, Cognitive abilities, Prediction of function recovery
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data recovery from language and cognitive assessmentOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months after stroke
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 18 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Jan 2023
- Primary completion30 Jun 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817642
- Sponsor's protocol ID
- APHP220542
- Acronym
- PREDICT-CALAP
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Language Recovery in Acute Stroke Patients in the Neurovascular Intensive Care Unit: An Exploratory Study With the Core Assessment of Language Processing.
- ClinicalTrials.gov ID
- NCT06817642
- Acronym / sponsor ID
- PREDICT-CALAP / APHP220542
- Conditions
- Stroke Patients
- Keywords
- Stroke, Aphasia, Language abilities, Cognitive abilities, Prediction of function recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients (hemispheric stroke, ischemic or hemorrhagic).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data recovery from language and cognitive assessmentData 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 | Other | – |
Primary outcome
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
4 secondary outcomes
Improving CALAP recovery prediction using MRI data
Time frame: 18 months after stroke
Improving CALAP recovery prediction using neuropsychological data
Time frame: 18 months after stroke
Cognitive recovery prediction with Core Assessment of Language Processing score
Time frame: 18 months after stroke
Improving CALAP recovery prediction using language rehabilitation data
Time frame: 18 months after stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne-Catherine BACHOUD-LEVI, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Catherine BACHOUD-LEVI, MD, PhD (01 49 81 43 01 ext. 0033, anne-catherine.bachoud-levi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language recovery prediction with Core Assessment of Language Processing score (time frame: 18 months after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.