Prosody Assessment After Right Hemisphere Stroke (ProsAVC)

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

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

-->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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with right stroke consecutively recruited according to inclusion and non-inclusion criteria
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of the inverse correlation task at the beginning and at the end of participation
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of musical perception
Time Frame: Inclusion, after 3 months and 6 months
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
Assessment of anxiety
Time Frame: Inclusion, after 3 months and 6 months
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
Assessment of depression
Time Frame: Inclusion, after 3 months and 6 months
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
Assessment of auditory attention
Time Frame: Inclusion, after 3 months and 6 months
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
Assessment of central auditory disorders
Time Frame: Inclusion, after 3 months and 6 months
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
Assessment of hearing acuity
Time Frame: Inclusion, after 3 months and 6 months
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
Event-Related Potentials (EEG)
Time Frame: Inclusion, after 3 months and 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marie VILLAIN, Ms., Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 15, 2023

Primary Completion (Anticipated)

February 14, 2025

Study Completion (Anticipated)

December 14, 2025

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Right Hemisphere Stroke

Clinical Trials on understanding of prosody

3
Subscribe