Prosody Assessment After Right Hemisphere Stroke (NCT05874011) | Clinical Trial Compass
RecruitingNot Applicable
Prosody Assessment After Right Hemisphere Stroke
France150 participantsStarted 2024-07-12
Plain-language summary
Following a right stroke, more than half of the patients present a communication disorder. These disorders can notably concern prosody. Nevertheless, these remain relatively poorly assessed and characterized. Prosodic alterations in comprehension can result in a disruption of social cognition with potentially important consequences in terms of functional outcome and quality of life of patients. In clinical practice, the investigators do not have a tool that allows us to finely assess these disorders.
Studies in healthy subjects using a processing algorithm capable of arbitrarily manipulating the pitch dynamics of recorded voices have revealed that there are stable internal representations for prosody processing. Initial pilot results show that this method can be used in a clinical context and can indeed identify and accurately measure perceptual processing deficits in prosody following a right stroke. It is necessary to continue the study of this approach with a larger number of subjects in order to have normative data and validate the diagnostic properties of this approach.
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: Inclusion criteria for patients
Patient:
* with a right supratentorial stroke (1st clinical episode of deficit) confirmed on imaging and less than 1 year old at the time of inclusion
* right-handed
* male and female over 18 years of age
* french mother tongue
* affiliated or beneficiary of a social security plan
* free, informed and written consent signed
* Inclusion criteria for control subjects:
Subject:
* no known history of stroke
* right-handed
* over 18 years of age and matched with a case on age (plus or minus 10 years)
* french mother tongue
* affiliated or beneficiary of a social security plan
* free, informed and written consent signed
--\>Exclusion Criteria: Non-inclusion criteria for patients and controls subjects
* comprehension disorders: score less than 10/15 on the BDAE (Boston Diagnostic Aphasia Examination) command execution test
* known dementia
* illiteracy
* severe dysarthria
* psychiatric history requiring hospitalization in a specialized environment for more than two months
* history of brain injury
* major visual or auditory perceptual disorder (hearing loss greater than 40 dB HL)
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?
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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.
What they're measuring
1
Evolution of the inverse correlation task at the beginning and at the end of participation