Pragmatic Assessment and Treatment for the Health System

Stroke Clinical Trial

— PATHS  

Official title:

"Assessment and Treatment of Communicative Pragmatic Abilities in Neurological and Psychiatric Disorders: Feasibility and Clinical Efficacy (PATHS)"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809401
• Other study ID #: 2019.10
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: Giorgio Arcara
• Phone: 0412207594
• Email: giorgio.arcara[@]hsancamillo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Schizophrenia
• Stroke
• Traumatic Brain Injury

Intervention

Behavioral:
• Pragmatic Rehabilitation
A series of behavioral activities to improve specific pragmatic abilities in patients
• Neuropsychological Rehabilitation
A series of behavioral activities to improve general aspect of cognition, with a specific focus on attentional abilities.

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milano	MI
Italy	Istituto Universitario di Studi Superiori Pavia	Pavia
Italy	IRCCS Eugenio Medea	Pieve Di Soligo	TV
Italy	IRCCS San Camillo Hospital	Venice

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy	IRCCS San Raffaele, Istituto Universitario di Studi Superiori Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in APACS-Brief scores (Assessment of Pragmatic Abilities and Cognitive Substrates - Brief).	A short test on pragmatic abilities. Scores range from 0 to 1. Higher values indicates better score	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	Change in EEG (Electroencephalography) activity - ASSR (Auditory Steady State Response)	EEG activity for ASSR is measured as power change in 40 Hz frequency as compared to baseline (time window from -100 to 0 ms). Score is unbounded. Higher values indicate better score (i.e., higher synchronization)	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	Change in EEG (Electroencephalography) activity - MMN (Mismatch Negativity)	EEG activity for MMN is measured as average voltage deflection in 150-250 ms time window (with -100-0 ms as baseline). Score is unbounded. Larger negative values indicated a better score (i.e., larger MMN)	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)