Neural and Cognitive Correlates of Pragmatic Abilities

Healthy Clinical Trial

— APACS_Neuro  

Official title:

Neural and Cognitive Correlates of Pragmatic Communication Abilities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06297044
• Other study ID #: 2017.20
• Status: Active, not recruiting
• Start date: March 29, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 324
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Neoplasms
• Cognitive Dysfunction
• Healthy
• Mild Cognitive Impairment
• Right Hemispheric Stroke
• Stroke
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
Italy	San Camillo IRCCS s.r.l.	Venice-Lido	Venice

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pragmatic Profile	results at ASsessemnt of Pragmatics Abilities and Cognitive Substrates (APACS) test	after enrollmnet (T0)
Secondary	Theory of Mind	Results at Story Empathy Test (SET) score	after enrollmnet (T0)
Secondary	Functional Communication Abilities	Results at Communication Outcome After Stroke (COAST)	after enrollmnet (T0)