Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia

NCT06930131 | Recruiting

• 2 other identifiers: RC31/22/05032024-A01842-45
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia; Stroke

Keywords

Aphasia; Stroke; Chronic; Cognitive rehabilitation; SCED

Outcome Measures

Primary Outcomes (1)

• Performance at the "TD-264" untrained naming items task

  The "TD-264 untrained naming items task" is a naming task of 264 images. Words corresponding to the images correctly named are "set success" and words wrongly named are "set treatment". The score at the task is composite : * reaction time allowing the speed of evocation to be measured will be measured with the Audacity software (https://audacity.fr/). * accuracy will be rated 1. quantitatively : number of "set success" 2. qualitatively : description of naming behaviors Scores are all from 0 to 264. 0 being the worst performance possible and 264 being the best performance possible.

  Baseline, Up to 8 weeks, Up to 13 weeks

Secondary Outcomes (1)

• Reorganization of patients' functional connectivity maps compared to healthy volunteers

  Up to 8 weeks ; Up to 13 weeks

Study Arms (3)

6 weeks phase A (Baseline)

OTHER

Behavioral: Semantic rehabilitation

7 weeks phase A (Baseline)

OTHER

Behavioral: Semantic rehabilitation

8 weeks phase A (Baseline)

OTHER

Behavioral: Semantic rehabilitation

Interventions

Semantic rehabilitation BEHAVIORAL

Semantic rehabilitation, consisting of validated lexico-phonological training exercises

6 weeks phase A (Baseline); 7 weeks phase A (Baseline); 8 weeks phase A (Baseline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Aphasia; Stroke; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Central Study Contacts

Lola DANET

CONTACT

05 61 77 76 86; danet.l@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: April 16, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)