Pragmatic Assessment and Treatment for the Health System
NCT ID: NCT05809401
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
330 participants
INTERVENTIONAL
2019-11-13
2025-07-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PRAGMACOM
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.
Pragmatic Rehabilitation
A series of behavioral activities to improve specific pragmatic abilities in patients
Standard Neuropsychological Treatment
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.
Neuropsychological Rehabilitation
A series of behavioral activities to improve general aspect of cognition, with a specific focus on attentional abilities.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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IRCCS San Raffaele
OTHER
Istituto Universitario di Studi Superiori Pavia
OTHER
IRCCS San Camillo, Venezia, Italy
OTHER
Responsible Party
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Principal Investigators
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Arcara
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Camillo Hospital
Locations
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IRCCS San Raffaele
Milan, MI, Italy
IRCCS Eugenio Medea
Pieve di Soligo, TV, Italy
Istituto Universitario di Studi Superiori Pavia
Pavia, , Italy
IRCCS San Camillo Hospital
Venice, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2019.10
Identifier Type: -
Identifier Source: org_study_id
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