Pragmatic Assessment and Treatment for the Health System

Last updated: March 14, 2024
Sponsor: IRCCS San Camillo, Venezia, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Neurologic Disorders

Cerebral Ischemia

Treatment

Pragmatic Rehabilitation

Neuropsychological Rehabilitation

Clinical Study ID

NCT05809401
2019.10
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The project goal is to promote a feasible and effective approach to communicative disorders in neurological and psychiatric populations, focused on the pragmatics of language. Pragmatics allows speakers to use and interpret language in context and to engage in successful communication. Pragmatic language disorder is widespread in clinical conditions and causes reduced social interactions and lower quality of life for both patients and their family. Yet it is seldom considered in assessment and rehabilitation.

Eligibility Criteria

Inclusion

Inclusion Criteria: Healthy participants

  • no neurological disorder
  • written informed consent Right Hemisphere Damage (RHD)
  • unilateral stroke
  • first stroke
  • no comorbidities with psychiatric disorders
  • written informed consent TBI
  • traumatic brain injury
  • written informed consent Schizophrenia:
  • Diagnosis of Schizophrenia
  • written informed consent

Exclusion

Exclusion Criteria:

  • Important comorbidities that may affect results

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Pragmatic Rehabilitation
Phase:
Study Start date:
November 13, 2019
Estimated Completion Date:
July 31, 2025

Study Description

The project aims at developing a comprehensive approach for the assessment and treatment of pragmatic impairment in neurological disease. It consists of three Work Packages:

  • The aim of WP1 is to develop a short test of pragmatic abilities. 200 healthy participants will be enrolled for this WP, and the same test will be administered to 40 patients with right hemisphere damage, 40 with traumatic brain injury, and 50 with Schizophrenia.

  • The aim of WP2 is to test the efficacy of a novel treatment for pragmatic disorder. 32 patients will be enrolled (16 for each patient group) and allocated (via Randomized Control Trial) to a standard treatment or to a novel treatment for pragmatic disorders. Only RHD and TBI will take part to this WP.

  • The aim of WP3 is to better clarify the neural correlates of pragmatic abilities. All patients will undergo an high density EEG recording session, and their brain activity will be correlated with performance on neuropsychological tests and on pragmatic impairment. The RHD and TBI patients enrolled for WP2 will undergo a session of hd-EEG also at the end of rehabilitation to monitor brain changes after treatment.

Connect with a study center

  • IRCCS San Raffaele

    Milano, MI
    Italy

    Active - Recruiting

  • IRCCS Eugenio Medea

    Pieve Di Soligo, TV 31053
    Italy

    Active - Recruiting

  • Istituto Universitario di Studi Superiori Pavia

    Pavia,
    Italy

    Active - Recruiting

  • IRCCS San Camillo Hospital

    Venice,
    Italy

    Active - Recruiting

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