Pragmatic Assessment and Treatment for the Health System
PATHS
"Assessment and Treatment of Communicative Pragmatic Abilities in Neurological and Psychiatric Disorders: Feasibility and Clinical Efficacy (PATHS)"
1 other identifier
interventional
330
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Nov 2019
Longer than P75 for not_applicable stroke
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2019
CompletedFirst Submitted
Initial submission to the registry
March 2, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedMarch 15, 2024
March 1, 2024
5.7 years
March 2, 2023
March 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in EEG (Electroencephalography) activity - ASSR (Auditory Steady State Response)
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)
Change in EEG (Electroencephalography) activity - MMN (Mismatch Negativity)
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)
Study Arms (2)
PRAGMACOM
EXPERIMENTALAn 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.
Standard Neuropsychological Treatment
ACTIVE COMPARATORThe standard treatment for neuropsychological disorders is administered to RHD, and TBI patients in the IRCCS San Camillo Hospital, which consists mostly of attentional training.
Interventions
A series of behavioral activities to improve specific pragmatic abilities in patients
A series of behavioral activities to improve general aspect of cognition, with a specific focus on attentional abilities.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Important comorbidities that may affect results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IRCCS San Camillo, Venezia, Italylead
- IRCCS San Raffaelecollaborator
- Istituto Universitario di Studi Superiori Paviacollaborator
Study Sites (4)
IRCCS San Raffaele
Milan, MI, Italy
IRCCS Eugenio Medea
Pieve di Soligo, TV, 31053, Italy
Istituto Universitario di Studi Superiori Pavia
Pavia, Italy
IRCCS San Camillo Hospital
Venice, Italy
Related 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.
PMID: 35526293BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arcara
IRCCS San Camillo Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2023
First Posted
April 12, 2023
Study Start
November 13, 2019
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
March 15, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share