Neural and Cognitive Correlates of Pragmatic Abilities

NCT06297044 | Active Not Recruiting

• 1 other identifier: 2017.20
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pragmatic Profile

  results at ASsessemnt of Pragmatics Abilities and Cognitive Substrates (APACS) test

  after enrollmnet (T0)

Secondary Outcomes (2)

• Theory of Mind

  after enrollmnet (T0)

• Functional Communication Abilities

  after enrollmnet (T0)

Study Arms (7)

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

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

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

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

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

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

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurological patients and healthy individuals

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

San Camillo IRCCS s.r.l.

Venice-Lido, Venice, 30126, Italy

Location

Related Publications (4)

• 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.

  PMID: 26903894 BACKGROUND

• 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.

  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.

  PMID: 26072203 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Giorgio Arcara

  San Camillo IRCCS Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 6, 2024
• Study Start: March 29, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)