NCT03622606

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
active not 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 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 21, 2024

Status Verified

March 1, 2024

Enrollment Period

4.7 years

First QC Date

July 2, 2018

Last Update Submit

August 20, 2024

Conditions

Stroke

Keywords

Right hemispheric StrokeCrossed aphasiaAcute phase

Outcome Measures

Primary Outcomes (1)

  • Score at R-LAST

    Internal validation: no item will present effect floor, ceiling or of redundancy. Validation inter examiner: the score obtained to R-LAST is independent from the examiner. External validation: the patients detected by gold standard as presenting a speech difficulty bound to a right hemispherical lesion will also be him by R-LAST (no forgery negatives), and that the patients not presenting speech difficulty during the signing of these standard gold will obtain the maximum score to R-LAST (no forgery positive).

    Day 1

Secondary Outcomes (4)

  • Score at LAST A and B

    Day 1

  • Time of signing R-LAST

    Day 1

  • Simplicity and convenience of R-LAST

    Day 1

  • Visual aspect of R-LAST

    Day 1

Study Arms (1)

Acute and subacute phase of right stroke

EXPERIMENTAL

The intervention will be the passation of Right Language Screening Test (R-LAST). Patients in acute phase of right hemispheric stroke will be used for the internal validation and the integrated reliability of the Right Language screening test. Patients in subacute phase of right hemispheric stroke will be used for the external validation of the Right Language screening test.

Diagnostic Test: Right Language screening test (R-LAST)

Interventions

Right Language screening test (R-LAST)DIAGNOSTIC_TEST

Validation of the Right Language screening test in acute and subacute phase of right stroke

Acute and subacute phase of right stroke

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CH Sud Francilien

Corbeil-Essonnes, 91106, France

Location

CH de Versailles

Le Chesnay, 78150, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Didier SMADJA, Neurologist

    Sud Francilien Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosciences doctor

Study Record Dates

First Submitted

July 2, 2018

First Posted

August 9, 2018

Study Start

September 25, 2018

Primary Completion

June 8, 2023

Study Completion

October 1, 2024

Last Updated

August 21, 2024

Record last verified: 2024-03

Locations

FR(2)