Clinical trial NCT06930131: Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Official title: Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aphasia
Stroke
Keywords: Aphasia
Stroke
Chronic
Cognitive rehabilitation
SCED
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The postulate of this study is that rehabilitation combining linguistic and metacognitive training will result in a significant improvement in language performance correlated with changes in functional cerebral connectivity networks. In addition, it could potentiate the generalisation of effects to verbal and non-verbal communication skills, having a direct impact on patients' quality of life. This research is a prospective, randomized controlled, open-label, single-centre study. It is part of the management of patients with aphasia who have suffered a cerebral infarction and aims to evaluate the effect of combined language semantics/metacognition rehabilitation.

Detailed description: Vascular aphasia occurs after 20 to 25% of strokes and leads to anomia or word-finding difficulties in many patients. Speech therapy, which is the standard treatment, notably employs Semantic Feature Analysis (SFA). SFA aims to teach patients a strategy that helps activate semantic links strongly associated with the target word, thereby facilitating word retrieval.

Moreover, a growing number of studies suggest combining metacognitive strategy training with language rehabilitation in brain-injured patients, particularly in reading comprehension, communication skills, and anomia, could improve cognitive and language recovery outcomes. In rehabilitation, metacognitive strategy training can be used to enhance and/or compensate for cognitive function deficits. Patients are repeatedly exposed to discrepancies between the patients performance evaluations and expectations. Findings indicate improvements in trained tasks and transfer effects to similar tasks.

While studies have examined the effects of linguistic training on one hand and the impact of metacognitive abilities on the other, to the investigators knowledge, no study has assessed the effect of a combined linguistic and metacognitive training approach in post-stroke aphasic patients on behavioral and imaging variables. This study postulates that rehabilitation combining linguistic and metacognitive training will lead to a significant improvement in language performance, correlated with changes in functional brain connectivity networks. Furthermore, it may enhance the generalization of effects to both verbal and non-verbal communication skills, directly impacting patients' quality of life.

Eligibility criteria: Inclusion Criteria:

* First cerebral infarction
* Chronic phase (\> 3 months)
* Patient affiliated to a health insurance scheme
* Usual french language
* Severity score measures using the Boston Diagnostic Aphasia Examination battery scale corresponding to the mild or moderate level (score greater than or equal to 2)

Exclusion Criteria:

* Contraindication to undergoing brain MRI
* Cognitive impairment pre-existing stroke (CQI code \> 3.4) (Law et al., 1995)
* Chronic alcohol or drug abuse
* Unstabilised psychiatric illness
* Uncorrected sensory deficits
* Diagnosed as having a progressive general pathology

Primary outcomes:
measure: Performance at the "TD-264" untrained naming items task
timeFrame: Baseline, Up to 8 weeks, Up to 13 weeks
Secondary outcomes:
measure: Reorganization of patients' functional connectivity maps compared to healthy volunteers
timeFrame: Up to 8 weeks ; Up to 13 weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
References: