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Right Hemisphere StrokeProsAVCNCT05874011

Prosody Assessment After Right Hemisphere Stroke

An observational study of Right Hemisphere Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Right Hemisphere Stroke
What is being tested?
understanding of prosody
How many people
26 participants
Where
1 siteFrance
Study dates
15 Jun 2026to 15 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Major patients with right supratentorial stroke and major control subjects with no known history of stroke will be enrolled in this study.

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Assistance Publique - Hôpitaux de Paris, Hôpital Pitié-Salpêtrière

    Paris, 75013

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
understanding of prosody
Keywords
Prosody, Reverse correlation, Stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • understanding of prosodyOther

    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

Study groups in NCT05874011
Study groupRoleWhat they receive
PatientsPatients with right stroke consecutively recruited according to inclusion and non-inclusion criteria
Receives: Other: understanding of prosody
Healthy volunteersHealthy volunteers with no known history of stroke
Receives: Other: understanding of prosody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (7)
  1. 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).

    Measured: Inclusion, after 3 months and 6 months

  2. 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.

    Measured: Inclusion, after 3 months and 6 months

  3. 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.

    Measured: Inclusion, after 3 months and 6 months

  4. 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).

    Measured: Inclusion, after 3 months and 6 months

  5. 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)

    Measured: Inclusion, after 3 months and 6 months

  6. Assessment of hearing acuity

    The hearing of the subjects will be measured by performing audiograms to ensure that there is no hearing loss.

    Measured: Inclusion, after 3 months and 6 months

  7. 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.

    Measured: Inclusion, after 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start15 Jun 2026
  3. Primary completion15 Jun 2026
  4. Study completion15 Jun 2026

Why it stopped: Slow patient/control enrollment, Missing data issues, And organizational and administrative difficulties.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05874011
Sponsor's protocol ID
APHP200144
Acronym
ProsAVC
Status last verified
Aug 2026
First submitted
5 May 2023
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Questions about this trial

What is this clinical trial studying?

An observational study of Right Hemisphere Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow patient/control enrollment, Missing data issues, And organizational and administrative difficulties.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of the inverse correlation task at the beginning and at the end of participation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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