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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05874011
Other study ID # APHP200144
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 15, 2023
Est. completion date December 14, 2025

Study information

Verified date April 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Marie VILLAIN, Ms.
Phone (0)6 72 34 60 26
Email marie.villain@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The aim of this project is to study impairments of speech prosodic perception using a novel data-driven psychoacoustic technique, reverse correlation. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 14, 2025
Est. primary completion date February 14, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility -->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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of the inverse correlation task at the beginning and at the end of participation The inverse correlation task that will be proposed in the study consists of presenting pairs of the word "really" with random variations in the height (F0) of the bounds of the six 71 ms segments of the word, asking them to distinguish within each pair which is the more interrogative. 6 months
Secondary Assessment of musical perception As the perception of prosody, whether linguistic or emotional, can be closely linked to musical perception, we will use the melodic part of the Montreal Amusia Assessment Battery (MBEA), considering the value of 65 as the pathological threshold, as established by the study by Peretz (Peretz, Champod, & Hyde, 2003). Inclusion, after 3 months and 6 months
Secondary Assessment of anxiety Mood disorders following a stroke may influence the perception and production of prosody. In order to assess the presence of such disorders in the study subjects, we will use the HADS (Hospital and Anxiety Depression Scale) (Friedman, Samuelian, Lancrenon, Even, & Chiarelli, 2001; Zigmond & Snaith, 1983) which is a self-administered questionnaire composed of 14 questions on anxiety and depressive symptoms. Inclusion, after 3 months and 6 months
Secondary Assessment of depression Mood disorders following a stroke may influence the perception and production of prosody. In order to assess the presence of such disorders in the study subjects, we will use the HADS (Hospital and Anxiety Depression Scale) (Friedman, Samuelian, Lancrenon, Even, & Chiarelli, 2001; Zigmond & Snaith, 1983) which is a self-administered questionnaire composed of 14 questions on anxiety and depressive symptoms. Inclusion, after 3 months and 6 months
Secondary Assessment of auditory attention To determine whether or not attentional components are affected, we will use crossmodal integration and flexibility subtests from the Test of Attentional Performance (TAP, version 2.3.1, Zimmermann and Fimm, 2009). Inclusion, after 3 months and 6 months
Secondary Assessment of central auditory disorders Difficulties in prosody perception may be due to central auditory disorders. Therefore, we will assess pitch, intensity and duration discrimination abilities using the AIRTAC2 software (Del Fabro & Desmons, 2014; Weill-Chounlamountry, Tessier, Soyez-Gayout, & Pradat-Diehl, 2010) Inclusion, after 3 months and 6 months
Secondary Assessment of hearing acuity The hearing of the subjects will be measured by performing audiograms to ensure that there is no hearing loss. Inclusion, after 3 months and 6 months
Secondary Event-Related Potentials (EEG) We will use an Electrical Geodesics device, consisting of a net of 256 electrodes wetted in a salt water solution and placed on the scalp; and a set of high impedance amplifiers connected to a Mac computer for digitising the signals. This is a method with excellent temporal resolution. Indeed, the entry into activity of a brain region is instantly accompanied by a tiny variation in electrical potential on the surface of the scalp, which the EEG amplifiers measure with extreme precision.
Typically, we digitise EEG signals between 125 Hz and 500 Hz, which allows a temporal accuracy of 2 to 8 milliseconds.
Inclusion, after 3 months and 6 months
See also
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