Clinical trial NCT06297044: Neural and Cognitive Correlates of Pragmatic Abilities
Official title: Neural and Cognitive Correlates of Pragmatic Communication Abilities
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Right Hemispheric Stroke
Left Hemispheric Stroke
Traumatic Brain Injury
Right Hemispheric Brain Tumor
Left Hemispheric Brain Tumor
Mild Cognitive Impairment
Healthy
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurological patients and healthy individuals

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.

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.

Primary outcomes:
measure: Pragmatic Profile
timeFrame: after enrollmnet (T0)
Secondary outcomes:
measure: Theory of Mind
timeFrame: after enrollmnet (T0)
measure: Functional Communication Abilities
timeFrame: after enrollmnet (T0)
Other outcomes:
Locations:
city: Venice-Lido
country: Italy
facility: San Camillo IRCCS s.r.l.
state: Venice
Study officials:
affiliation: San Camillo IRCCS Hospital
name: Giorgio Arcara
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
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.