StrokeR-LASTNCT03622606
Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
A study testing Right Language screening test (R-LAST) in people with Stroke, run by Versailles Hospital at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Right Language screening test (R-LAST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Sep 2018to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 18Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH Sud Francilien
Corbeil-Essonnes, 91106
CH de Versailles
Le Chesnay, 78150
About this study
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
Read the 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)
- Conditions
- Stroke
- Being tested
- Right Language screening test (R-LAST)
- Keywords
- Right hemispheric Stroke, Crossed aphasia, Acute phase
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Language screening test (R-LAST)Diagnostic test
Validation of the Right Language screening test in acute and subacute phase of right stroke
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Right Language screening test (R-LAST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Secondary outcomes (4)
Score at LAST A and B
Detect the patients presenting a right hemispherical AVC with crossed aphasia "mirror"
Measured: Day 1
Time of signing R-LAST
To obtain an average time of signing which will have to be shorter than that of the standard gold used during the external validation.
Measured: Day 1
Simplicity and convenience of R-LAST
Contains only a sheet printed in black and white and both sides (to avoid the semantic indications bound to the color of an item, and to simplify the reproduction).
Measured: Day 1
Visual aspect of R-LAST
Presentation in "portrait" mode, so that patients presenting a neurovisual disorder of type héminégligence or héminanopsie controlatérale are not penalized
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start25 Sep 2018
- Primary completion8 Jun 2023
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Sud Francilien
- Responsible party
- Principal investigator, Dr Constance FLAMAND-ROZE, Versailles Hospital
- Investigators
- Didier SMADJA, Neurologist, Principal investigator, Sud Francilien Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622606
- Sponsor's protocol ID
- P17/07_R-LAST
- Acronym
- R-LAST
- Status last verified
- Mar 2024
- First submitted
- 2 Jul 2018
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
- ClinicalTrials.gov ID
- NCT03622606
- Acronym / sponsor ID
- R-LAST / P17/07_R-LAST
- Conditions
- Stroke
- Keywords
- Right hemispheric Stroke, Crossed aphasia, Acute phase
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Collaborators
- Centre Hospitalier Sud Francilien
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- Oct 2024 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute and subacute phase of right stroke | Experimental | Diagnostic Test: Right Language screening test (R-LAST)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Language screening test (R-LAST)Validation of the Right Language screening test in acute and subacute phase of right stroke | Diagnostic test | Acute and subacute phase of right stroke |
Primary outcome
Score at R-LAST
Time frame: Day 1
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).
4 secondary outcomes
Score at LAST A and B
Time frame: Day 1
Time of signing R-LAST
Time frame: Day 1
Simplicity and convenience of R-LAST
Time frame: Day 1
Visual aspect of R-LAST
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier SMADJA, Neurologist principal investigator
Sud Francilien Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Language screening test (R-LAST) in people with Stroke, run by Versailles Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score at R-LAST (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.