Clinical trial NCT05809401: Pragmatic Assessment and Treatment for the Health System
Official title: "Assessment and Treatment of Communicative Pragmatic Abilities in Neurological and Psychiatric Disorders: Feasibility and Clinical Efficacy (PATHS)"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Traumatic Brain Injury
Schizophrenia
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
name: Istituto Universitario di Studi Superiori Pavia
First posted: 2023-04-12
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in APACS-Brief scores (Assessment of Pragmatic Abilities and Cognitive Substrates - Brief).
timeFrame: for healthy participants and all patients only t0 (immediatly after enrollment. For patients selected for WP2, T0 (after enrollment, as baseline) and T1 (after the treatment, that is after 1.5 months on average)
Secondary outcomes:
measure: Change in EEG (Electroencephalography) activity - ASSR (Auditory Steady State Response)
timeFrame: for healthy participants and all patients only t0 (immediatly after enrollment. For patients selected for WP2, T0 (after enrollment, as baseline) and T1 (after the treatment, that is after 1.5 months on average)
measure: Change in EEG (Electroencephalography) activity - MMN (Mismatch Negativity)
timeFrame: for healthy participants and all patients only t0 (immediatly after enrollment. For patients selected for WP2, T0 (after enrollment, as baseline) and T1 (after the treatment, that is after 1.5 months on average)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele
state: MI
city: Pieve Di Soligo
country: Italy
facility: IRCCS Eugenio Medea
state: TV
city: Pavia
country: Italy
facility: Istituto Universitario di Studi Superiori Pavia
city: Venice
country: Italy
facility: IRCCS San Camillo Hospital
Study officials:
affiliation: IRCCS San Camillo Hospital
name: Arcara
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bambini V, Agostoni G, Buonocore M, Tonini E, Bechi M, Ferri I, Sapienza J, Martini F, Cuoco F, Cocchi F, Bischetti L, Cavallaro R, Bosia M. It is time to address language disorders in schizophrenia: A RCT on the efficacy of a novel training targeting the pragmatics of communication (PragmaCom). J Commun Disord. 2022 May-Jun;97:106196. doi: 10.1016/j.jcomdis.2022.106196. Epub 2022 Feb 2.