Neural and Cognitive Correlates of Pragmatic Abilities

Active, not recruiting

• Conditions: Healthy; Right Hemispheric Stroke; Mild Cognitive Impairment; Traumatic Brain Injury; Right Hemispheric Brain Tumor; Left Hemispheric Stroke; Left Hemispheric Brain Tumor
• Interventions: Other: Neuropsychological assessment

• Registration Number: NCT06297044
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

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.

Study Timeline

• Study Start: 2018-03-29
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 324

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Traumatic Brain Injury	Neuropsychological assessment	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.
Healthy Individuals	Neuropsychological assessment	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.
Right Hemispheric Stroke	Neuropsychological assessment	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.
Left Hemispheric Stroke	Neuropsychological assessment	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.
Mild Cognitive Impairment	Neuropsychological assessment	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.
Right Hemispheric Brain Tumor	Neuropsychological assessment	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.
Left Hemispheric Brain Tumor	Neuropsychological assessment	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.

Primary Outcome Measures

Name	Time	Method
Pragmatic Profile	after enrollmnet (T0)	results at ASsessemnt of Pragmatics Abilities and Cognitive Substrates (APACS) test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

San Camillo IRCCS s.r.l.; 🇮🇹 Venice-Lido, Venice, Italy