NCT06817642Recruiting
Predicting Language Recovery in Acute Stroke Patients in the Neurovascular Intensive Care Unit: An Exploratory Study With the Core Assessment of Language Processing.
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 570 (estimated)
- First submitted
- 5 Jul 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Stroke
- NCT number
- NCT06817642
What you commit to
- Study type: Observational
- Planned participants: 570
- From 1 Jan 2023 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe alertness impairment incompatible with test participation, NIHSS score 1a. different from 0
- Patients who may have a visual or hearing impairment incompatible with participation in CALAP
- History of stroke
- Posterior fossa stroke
Other
- Severe overall intellectual deterioration incompatible with test participation
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.