Clinical trial NCT05874011: Prosody Assessment After Right Hemisphere Stroke
Official title: Development of a Tool to Assess Receptive Prosody in the Aftermath of a Right Stroke: Use of the Inverse Correlation Paradigm
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Right Hemisphere Stroke
Keywords: Prosody
Reverse correlation
Stroke
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patients with right supratentorial stroke and major control subjects with no known history of stroke will be enrolled in this study.

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.

Detailed 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.

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)

Primary outcomes:
measure: Evolution of the inverse correlation task at the beginning and at the end of participation
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of musical perception
timeFrame: Inclusion, after 3 months and 6 months
measure: Assessment of anxiety
timeFrame: Inclusion, after 3 months and 6 months
measure: Assessment of depression
timeFrame: Inclusion, after 3 months and 6 months
measure: Assessment of auditory attention
timeFrame: Inclusion, after 3 months and 6 months
measure: Assessment of central auditory disorders
timeFrame: Inclusion, after 3 months and 6 months
measure: Assessment of hearing acuity
timeFrame: Inclusion, after 3 months and 6 months
measure: Event-Related Potentials (EEG)
timeFrame: Inclusion, after 3 months and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie VILLAIN, Ms.
role: PRINCIPAL_INVESTIGATOR
References: