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Neural and Cognitive Correlates of Pragmatic Abilities (APACS_Neuro)

I

IRCCS San Camillo, Venezia, Italy

Status

Active, not recruiting

Conditions

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

Treatments

Other: Neuropsychological assessment

Study type

Observational

Funder types

Other

Identifiers

NCT06297044
2017.20

Details and patient eligibility

About

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.

Full 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.

Enrollment

324 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 design

324 participants in 7 patient groups

Right Hemispheric Stroke
Description:
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.
Treatment:
Other: Neuropsychological assessment
Left Hemispheric Stroke
Description:
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.
Treatment:
Other: Neuropsychological assessment
Traumatic Brain Injury
Description:
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.
Treatment:
Other: Neuropsychological assessment
Right Hemispheric Brain Tumor
Description:
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.
Treatment:
Other: Neuropsychological assessment
Left Hemispheric Brain Tumor
Description:
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.
Treatment:
Other: Neuropsychological assessment
Mild Cognitive Impairment
Description:
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.
Treatment:
Other: Neuropsychological assessment
Healthy Individuals
Description:
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.
Treatment:
Other: Neuropsychological assessment

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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