Neural and Cognitive Correlates of Pragmatic Abilities

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Neural and Cognitive Correlates of Pragmatic Abilities

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06297044
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	IRCCS San Camillo, Venezia, Italy
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Giorgio Arcara
Principal Investigator Affiliation	San Camillo IRCCS Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Right Hemispheric Stroke, Left Hemispheric Stroke, Traumatic Brain Injury, Right Hemispheric Brain Tumor, Left Hemispheric Brain Tumor, Mild Cognitive Impairment, Healthy

Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

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

Status

Address

San Camillo IRCCS s.r.l.

Venice-Lido, Venice, 30126

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