Pragmatic Assessment and Treatment for the Health System (PATHS)

IRCCS San Camillo, Venezia, Italy

Status: Enrolling

Conditions: Traumatic Brain Injury; Stroke; Schizophrenia

Treatments: Behavioral: Neuropsychological Rehabilitation; Behavioral: Pragmatic Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05809401

2019.10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 criteria

• Important comorbidities that may affect results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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330 participants in 2 patient groups

PRAGMACOM

Experimental group

Description:

An experimental treatment for pragmatic disorders characterized by activities that focus on conversational rules and on understanding figurative language. The treatment is already tested on Schizophrenic patients.

Treatment:

Behavioral: Pragmatic Rehabilitation

Standard Neuropsychological Treatment

Active Comparator group

Description:

The standard treatment for neuropsychological disorders is administered to RHD, and TBI patients in the IRCCS San Camillo Hospital, which consists mostly of attentional training.

Treatment:

Behavioral: Neuropsychological Rehabilitation