Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
150 participants
OBSERVATIONAL
2024-07-12
2027-01-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
NCT03622606
Clinical Prognosis After Stroke in Nonagenarian Patients Treated With Thrombolysis or Mechanical Thrombectomy
NCT04553237
Modulation of Cortical Gamma Synchrony in Stroke
NCT05830617
Correlates Between EEG Microstates and Clinical Characteristics of People With Stroke
NCT05519631
Prognostic Markers of Post-Stroke Depression (PROMoSD)
NCT05580198
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The project will, first, conduct a prospective diagnostic study on N=150 stroke patients and controls, in order to evaluate the relevance of reverse-correlation data as a marker of prosodic impairments. Second, the project will use this novel patient data for theoretical investigations such as lesion-symptom mapping, in order to better understand how prosodic processing differs between patients and controls. Finally, the project will develop a novel mobile audio-health platform to facilitate the adoption of the reverse-correlation procedure in clinical practice and to collect remote patient data to assist medical decision-making.
The rationale of the reverse correlation technique is to uncover a listener's mental representation of certain prosodic patterns (e.g. the different intonation of "really?" vs "really!") by analyzing a large set of responses to random stimuli.
The expected results of the project are threefold: (1) the investigators will provide a new tool able to diagnose stroke-related prosody impairments beyond existing gold standards, (2) the investigators will provide a finer characterization of symptomatological profiles in these patients and (3) the investigators will provide a new prognosis metric, implemented in a mobile application, to quantify how well a patient reacts to speech therapy day after day.
The project will both further our understanding of aprosodia and provide new clinical tools to improve its diagnosis and rehabilitation. Beyond stroke, the project will also provide a case-study for the application of reverse-correlation to general speech therapy practice, benefiting patients across the whole spectrum of hearing impairments.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients
Patients with right stroke consecutively recruited according to inclusion and non-inclusion criteria
understanding of prosody
The inverse correlation test consists of having the same word heard twice, and asking which of the two sounds the most like a question. The exercise will be repeated several times, for a task that will take a total of about thirty minutes
Healthy volunteers
Healthy volunteers with no known history of stroke
understanding of prosody
The inverse correlation test consists of having the same word heard twice, and asking which of the two sounds the most like a question. The exercise will be repeated several times, for a task that will take a total of about thirty minutes
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
understanding of prosody
The inverse correlation test consists of having the same word heard twice, and asking which of the two sounds the most like a question. The exercise will be repeated several times, for a task that will take a total of about thirty minutes
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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
* 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)
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marie VILLAIN, Ms.
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assistance Publique - Hôpitaux de Paris, Hôpital Pitié-Salpêtrière
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP200144
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.