NCT05874011 Prosody Assessment After Right Hemisphere Stroke
| NCT ID | NCT05874011 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Right Hemisphere Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-07-12 |
| Primary Completion | 2026-07-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-07-12 with a primary completion date of 2026-07-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
--\>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)
Contact & Investigator
Marie VILLAIN, Ms.
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05874011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Right Hemisphere Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05874011 currently recruiting?
Yes, NCT05874011 is actively recruiting participants. Contact the research team at marie.villain@aphp.fr for enrollment information.
Where is the NCT05874011 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05874011 clinical trial?
NCT05874011 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Marie VILLAIN, Ms. at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 150 participants.
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