NCT07766356

Brief Summary

In France, stroke affects 150,000 people annually and is the leading cause of acquired disability in adults; 10-12% of patients exhibit mild post-stroke aphasia, a condition defined by language difficulties. Few studies describe mild post-stroke aphasia, and none characterize the impairment of linguistic executive control in this population; consequently, its prevalence remains unknown. To date, the role of linguistic executive control in mild aphasia remains an open question. The aim of this project is to investigate linguistic executive control impairment in stroke survivors with mild aphasia, provide an initial estimate of its prevalence, and demonstrate its interactions with other linguistic and communicative aspects, as well as with executive and attentional functions.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
25mo left

Started Sep 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2028

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

July 20, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

strokeaphasiaAVC

Outcome Measures

Primary Outcomes (1)

  • measure the proportion of patients with mild post-stroke aphasia exhibiting deficits in linguistic executive control within three months of a first stroke

    CATEX score result (deficit score if below the mean value minus 1.65 times the standard deviation)

    7 days after the inclusion

Secondary Outcomes (6)

  • Study of the correlation between executive control of language (CATEX score) and the score of the test evaluating access to the lexical stock

    7 days after the inclusion

  • Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating access to the semantic system

    7 days after the inclusion

  • Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating non-verbal executive control

    7 days after the inclusion

  • Study of the correlation between linguistic executive control (CATEX score) and the score of the test evaluating gnosies

    7 days after the inclusion

  • Identification of patients' cognitive-linguistic impairment profiles based on cognitive test scores

    7 days after the inclusion

  • +1 more secondary outcomes

Study Arms (1)

Patients whose neuropsychological and speech-language pathology tests will be randomized

EXPERIMENTAL
Diagnostic Test: Neuropsychological testsDiagnostic Test: Speech-language assessments

Interventions

Patients undergo neuropsychological tests, the order of which will be randomized.

Patients whose neuropsychological and speech-language pathology tests will be randomized

Patients will undergo speech-language assessments, with the order of the tests randomized.

Patients whose neuropsychological and speech-language pathology tests will be randomized

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who has experienced a first ischemic stroke resulting in clinical symptoms within the last 3 months and is receiving care in the Physical Medicine and Rehabilitation department.
  • Score ≤ 31 on the conversational speech observation scale of the MEC test (Montreal Protocol for the Evaluation of Communication).
  • Patients with a BDAE score ≥ 3 (Boston Diagnostic Aphasia Examination - French version, Mazaux J.-M. \[1990\]); this score is the gold standard in aphasiology.
  • Native French-speaking patient capable of understanding oral or written instructions.

You may not qualify if:

  • Patients exhibiting behavior or a clinical condition incompatible with test administration, as assessed by the clinician.
  • Known major visual, auditory, or motor impairments incompatible with test performance.
  • Known neurodegenerative and/or neurodevelopmental disorders.
  • Known social cognition disorders (e.g., ASD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Médecine Physique et de Réadaptation Hôpital Raymonde Fournet Purpan

Toulouse, 31300, France

Location

MeSH Terms

Conditions

StrokeAphasia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2026

First Posted

August 14, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 8, 2028

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations