Neural and Cognitive Correlates of Pragmatic Abilities (APACS_Neuro)

Neural and Cognitive Correlates of Pragmatic Communication Abilities

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy; Traumatic Brain Injury; Mild Cognitive Impairment; Right Hemispheric Stroke; Left Hemispheric Stroke; Right Hemispheric Brain Tumor; Left Hemispheric Brain Tumor
• Intervention / Treatment: Other: Neuropsychological assessment

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.

• Study Type: Observational
• Enrollment (Estimated): 324

Contacts and Locations

Study Locations

• Italy
  • Venice
    • Venice-Lido, Venice, Italy, 30126
      • San Camillo IRCCS s.r.l.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Neurological patients and healthy individuals

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.
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.	Other: 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.
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.	Other: 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.
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.	Other: 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.
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.	Other: 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.
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.	Other: 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.
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pragmatic Profile	results at ASsessemnt of Pragmatics Abilities and Cognitive Substrates (APACS) test	after enrollmnet (T0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Theory of Mind	Results at Story Empathy Test (SET) score	after enrollmnet (T0)
Functional Communication Abilities	Results at Communication Outcome After Stroke (COAST)	after enrollmnet (T0)

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy
• Investigators: Principal Investigator: Giorgio Arcara, San Camillo IRCCS Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Central Nervous System Neoplasms; Nervous System Neoplasms; Cognition Disorders; Stroke; Brain Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction; Brain Neoplasms
• Other Study ID Numbers: 2017.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No