Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes (NCT03622606) | Clinical Trial Compass
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Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
France400 participantsStarted 2018-09-25
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.