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Recruiting NCT05874011

Prosody Assessment After Right Hemisphere Stroke

Observational Right Hemisphere Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: understanding of prosody.
Who it may be relevant to
Registry conditions: Right Hemisphere Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development of a Tool to Assess Receptive Prosody in the Aftermath of a Right Stroke: Use of the Inverse Correlation Paradigm

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Evolution of the inverse correlation task at the beginning and at the end of participation [Time frame: 6 months]
Secondary outcome measures (7)
  • Assessment of musical perception [Time frame: Inclusion, after 3 months and 6 months]
  • Assessment of anxiety [Time frame: Inclusion, after 3 months and 6 months]
  • Assessment of depression [Time frame: Inclusion, after 3 months and 6 months]
  • Assessment of auditory attention [Time frame: Inclusion, after 3 months and 6 months]
  • Assessment of central auditory disorders [Time frame: Inclusion, after 3 months and 6 months]
  • Assessment of hearing acuity [Time frame: Inclusion, after 3 months and 6 months]
  • Event-Related Potentials (EEG) [Time frame: Inclusion, after 3 months and 6 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Assistance Publique - Hôpitaux de Paris, Hôpital Pitié-Salpêtrière — Paris

Identifiers

NCT: NCT05874011 · APHP200144

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗