Clinical trial NCT03622606: Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
Official title: Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Right hemispheric Stroke
Crossed aphasia
Acute phase
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Sud Francilien
First posted: 2018-08-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a bi-centric study whose main objective is the validation of a rapid screening test for language disorders in the acute phase of right hemisphere stroke.

Primary objective

The main objective is the validation of a rapid language disorder screening tool that will be used in the acute phase of right hemispheric stroke.

Secondary objectives

Secondary objectives are:

* Characterize the "atypical crossed aphasia" since the acute phase of stroke with a large cohort of patients , which, to our knowledge, has never been done.
* Re-evaluate the number of patients with acute language disorder in right hemisphere stroke.
* Validate the use of R-LAST by different categories of carers

Detailed description: The R-LAST (Right Language screening test) comprises 8 subtests and a total of 15 items.

Validation will focus on the internal validity (no ceiling or floor effect, no redundancy, internal consistency), the external validity (against a "gold standard" in order to evaluate its specificity and its sensitivity) and the interclass agreement of R-LAST. The median time to administrate de scale will be calculated.

The investigators will validate the scale by administering it to 300 consecutive patients within 24 hours after admission to our 2 stroke units (Centre Hospitalier de Versailles and Centre hospitalier du sud francilien) and to 100 stabilized patients with and without atypical crossed aphasia using the MEC-P evaluation as a reference.

Patients must be 100% right-handed (Edinburgh test), be of French mother tongue, have no history of neurological disease, have no sensory disturbances (blindness, deafness) and no mirror crossed aphasia detected by the LAST (minimum score of 14/15 with a loss point granted for the "automatic speech" subtest, potentially stranded in right strokes)

Eligibility criteria: Inclusion Criteria:

* patients must be the age of majority
* Patients with right hemispheric stroke in the acute phase (internal validation + inter-examiner validation) or stabilization phase (external validation) confirmed by MRI or CT when MRI contraindicated
* Patient with no "mirror" crossed aphasia detected by the LAST procedure (A or B): LAST\> 14
* Patients who read the newsletter
* Affiliation to a social security scheme

Criteria Exclusion:

* Minor patients
* No French speakers
* Patients with a history of stroke
* Patients with dementia
* Patients with sensory impairment: deafness, blindness
* Patient not 100% right handed in the Edinburgh questionnaire
* Inability to answer the Edinburgh Laterality Questionnaire and absence of any person to fill in the questionnaire.
* Patient with a left-handed person in its family
* Illiterate patients
* Patient presenting a "mirror" crossed aphasia detected by LAST A or B (score tolerated: 14/15 with error accepted to the automatic speech)
* Inability to receive the information letter about the protocol and to read the newsletter
* Refusal of the patient

Primary outcomes:
measure: Score at R-LAST
timeFrame: Day 1
Secondary outcomes:
measure: Score at LAST A and B
timeFrame: Day 1
measure: Time of signing R-LAST
timeFrame: Day 1
measure: Simplicity and convenience of R-LAST
timeFrame: Day 1
measure: Visual aspect of R-LAST
timeFrame: Day 1
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: CH Sud Francilien
city: Le Chesnay
country: France
facility: CH de Versailles
Study officials:
affiliation: Sud Francilien Hospital
name: Didier SMADJA, Neurologist
role: PRINCIPAL_INVESTIGATOR
References: