Neural and Cognitive Correlates of Pragmatic Abilities

NCT ID: NCT06297044

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2025-12-31

Brief Summary

Pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. Disorders in the pragmatics of language are prevalent in various clinical populations. They are a cause of social withdrawal and worse quality of life, both for patients directly affected and for their family members. Despite this, this type of disorder is rarely considered in neuropsychological assessment and rehabilitation.

This study's objective is to characterize pragmatic deficits in various neurological populations, allowing for the most accurate diagnosis possible and leading to the planning of personalized and effective Rehabilitation Plans.

Detailed Description

To delineate the pragmatic deficit profile for each pathology group, eligible participants will undergo a neuropsychological assessment, subdivided into as many sessions as per the participant's availability and tolerance.

Assessment tools will include:

• APACS (A test for the Assessment of Pragmatic Abilities and Cognitive Substrates; Arcara and Bambini, 2016)
• SET (Story-based Empathy Task, Dodich et al., 2015)
• COAST (Communication Outcome After Stroke, Bambini et al., 2016)
• PWB (Psychological Well-Being scales, Sirigatti et al., 2009)
• other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Resulting test scores will be statistically analyze to provide pragmatic and cognitive profiles for each pathology.

Conditions

Right Hemispheric Stroke; Left Hemispheric Stroke; Traumatic Brain Injury; Right Hemispheric Brain Tumor; Left Hemispheric Brain Tumor; Mild Cognitive Impairment; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Right Hemispheric Stroke

Specific inclusion criteria for this participants' group are:

• unilateral right hemispheric lesion after an ischemic or hemorrhagic stroke.

There are no specific exclusion criteria for this participants' group (see general exclusion criteria).

Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections.

Neuropsychological assessment

Intervention Type: OTHER

• APACS assessing various aspects of pragmatic communication abilities;
• SET assessing cognitive and emotional theory of mind;
• COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset;
• PWB assessing the individual's perceived quality of life and psychological well-being;
• other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Left Hemispheric Stroke

Specific inclusion criteria for this participants' group are:

• unilateral left hemispheric lesion after an ischemic or hemorrhagic stroke.

There are no specific exclusion criteria for this participants' group (see general exclusion criteria).

Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections.

Neuropsychological assessment

Intervention Type: OTHER

• APACS assessing various aspects of pragmatic communication abilities;
• SET assessing cognitive and emotional theory of mind;
• COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset;
• PWB assessing the individual's perceived quality of life and psychological well-being;
• other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Traumatic Brain Injury

Specific inclusion criteria for this participants' group are:

• presence of a traumatic brain injury episode
• absence of previous neurological and psychiatric conditions.

There are no specific exclusion criteria for this participants' group (see general exclusion criteria).

Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections.

Neuropsychological assessment

Intervention Type: OTHER

• APACS assessing various aspects of pragmatic communication abilities;
• SET assessing cognitive and emotional theory of mind;
• COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset;
• PWB assessing the individual's perceived quality of life and psychological well-being;
• other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Right Hemispheric Brain Tumor

Specific inclusion criteria for this participants' group are:

• unilateral right hemispheric brain tumor.

There are no specific exclusion criteria for this participants' group (see general exclusion criteria).

Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections.

Neuropsychological assessment

Intervention Type: OTHER

• APACS assessing various aspects of pragmatic communication abilities;
• SET assessing cognitive and emotional theory of mind;
• COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset;
• PWB assessing the individual's perceived quality of life and psychological well-being;
• other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Left Hemispheric Brain Tumor

Specific inclusion criteria for this participants' group are:

• unilateral left hemispheric brain tumor.

There are no specific exclusion criteria for this participants' group (see general exclusion criteria).

Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections.

Neuropsychological assessment

Intervention Type: OTHER

• APACS assessing various aspects of pragmatic communication abilities;
• SET assessing cognitive and emotional theory of mind;
• COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset;
• PWB assessing the individual's perceived quality of life and psychological well-being;
• other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Mild Cognitive Impairment

Specific inclusion criteria for this participants' group are:

• MCI diagnosis according to Petersen et al., 2006 criteria
• absence of previous neurological and psychiatric conditions.

There are no specific exclusion criteria for this participants' group (see general exclusion criteria).

Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections.

Neuropsychological assessment

Intervention Type: OTHER

• APACS assessing various aspects of pragmatic communication abilities;
• SET assessing cognitive and emotional theory of mind;
• COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset;
• PWB assessing the individual's perceived quality of life and psychological well-being;
• other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Healthy Individuals

Specific inclusion criteria for this participants' group are:

• absence of neurological and psychiatric conditions.

There are no specific exclusion criteria for this participants' group (see general exclusion criteria).

Participants will undergo a detailed neuropsychological assessment as detailed in the study's detailed description and outcome measures sections.

Neuropsychological assessment

Intervention Type: OTHER

• APACS assessing various aspects of pragmatic communication abilities;
• SET assessing cognitive and emotional theory of mind;
• COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset;
• PWB assessing the individual's perceived quality of life and psychological well-being;
• other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Interventions

Neuropsychological assessment

• APACS assessing various aspects of pragmatic communication abilities;
• SET assessing cognitive and emotional theory of mind;
• COAST assessing functional communication impairments in daily activities and their impact on the quality of life after the illness onset;
• PWB assessing the individual's perceived quality of life and psychological well-being;
• other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Presence of objective neuropsychological assessment using standardized tests used in clinical routine.
• Ability to knowingly provide written informed consent and , therefore preserved comprehension skills and good understanding of simple verbal requests (for the experimental phase).
• Being a native speaker of Italian.

Exclusion Criteria

• Presence of disability that impairs participation in research.
• Insufficient knowledge of the Italian language.
• Refusal to participate in the research.
• Other relevant prior neurological or psychiatric conditions (other than those determining membership in the experimental group).
• Comorbidity of multiple conditions that would determine membership in more than one experimental group.
• Comorbidity with other neurological conditions.
• Presence of prior psychiatric conditions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giorgio Arcara

Role: PRINCIPAL_INVESTIGATOR

San Camillo IRCCS Hospital

Locations

San Camillo IRCCS s.r.l.

Venice-Lido, Venice, Italy

Countries

Italy

References

Arcara G, Bambini V. A Test for the Assessment of Pragmatic Abilities and Cognitive Substrates (APACS): Normative Data and Psychometric Properties. Front Psychol. 2016 Feb 12;7:70. doi: 10.3389/fpsyg.2016.00070. eCollection 2016.

Reference Type: BACKGROUND

PMID: 26903894 (View on PubMed)

Bambini, V., Arcara, G., Aiachini, B., Cattani, B., Dichiarante, M. L., Moro, A., ... & Pistarini, C. (2017). Assessing functional communication: validation of the Italian versions of the Communication Outcome after Stroke (COAST) scales for speakers and caregivers. Aphasiology, 31(3), 332-358.

Reference Type: BACKGROUND

Dodich A, Cerami C, Canessa N, Crespi C, Iannaccone S, Marcone A, Realmuto S, Lettieri G, Perani D, Cappa SF. A novel task assessing intention and emotion attribution: Italian standardization and normative data of the Story-based Empathy Task. Neurol Sci. 2015 Oct;36(10):1907-12. doi: 10.1007/s10072-015-2281-3. Epub 2015 Jun 14.

Reference Type: BACKGROUND

PMID: 26072203 (View on PubMed)

Sirigatti, S., Stefanile, C., Giannetti, E., Iani, L., Penzo, I., & Mazzeschi, A. (2009). Assessment of factor structure of Ryff's Psychological Well-Being Scales in Italian adolescents. Bollettino di Psicologia Applicata, 259(56), 30-50.

Reference Type: BACKGROUND

Other Identifiers

2017.20

Identifier Type: -

Identifier Source: org_study_id