NCT05874011

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Jul 2024Jan 2027

First Submitted

Initial submission to the registry

May 5, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 12, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

May 5, 2023

Last Update Submit

January 21, 2026

Conditions

Keywords

ProsodyReverse correlationStroke

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (7)

  • Assessment of musical perception

    Inclusion, after 3 months and 6 months

  • Assessment of anxiety

    Inclusion, after 3 months and 6 months

  • Assessment of depression

    Inclusion, after 3 months and 6 months

  • Assessment of auditory attention

    Inclusion, after 3 months and 6 months

  • Assessment of central auditory disorders

    Inclusion, after 3 months and 6 months

  • +2 more secondary outcomes

Study Arms (2)

Patients

Patients with right stroke consecutively recruited according to inclusion and non-inclusion criteria

Other: understanding of prosody

Healthy volunteers

Healthy volunteers with no known history of stroke

Other: understanding of prosody

Interventions

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 volunteersPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patient:
  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris, Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marie VILLAIN, Ms.

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie VILLAIN, Ms.

CONTACT

Anne BISSERY, Ms.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 24, 2023

Study Start

July 12, 2024

Primary Completion (Estimated)

July 12, 2026

Study Completion (Estimated)

January 11, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations