Right Hemisphere Stroke Clinical Trial
— ProsAVCOfficial 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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 14, 2025 |
Est. primary completion date | February 14, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | -->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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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 | 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). | Inclusion, after 3 months and 6 months | |
Secondary | 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. | Inclusion, after 3 months and 6 months | |
Secondary | 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. | Inclusion, after 3 months and 6 months | |
Secondary | 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). | Inclusion, after 3 months and 6 months | |
Secondary | 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) | Inclusion, after 3 months and 6 months | |
Secondary | Assessment of hearing acuity | 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 | |
Secondary | 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. |
Inclusion, after 3 months and 6 months |
Status | Clinical Trial | Phase | |
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Completed |
NCT00663338 -
Dopamine Agonist for Hemispatial Neglect and Motor Deficit Post Stroke
|
Phase 2 |