NCT06817642 Predicting Language Recovery in Acute Stroke Patients in the Neurovascular Intensive Care Unit: An Exploratory Study With the Core Assessment of Language Processing.
| NCT ID | NCT06817642 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Stroke Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 570 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 570 participants in total. It began in 2023-01-01 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06817642 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06817642 currently recruiting?
Yes, NCT06817642 is actively recruiting participants. Contact the research team at anne-catherine.bachoud-levi@aphp.fr for enrollment information.
Where is the NCT06817642 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT06817642 clinical trial?
NCT06817642 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 570 participants.
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