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| Name | Class |
|---|---|
| IRCCS San Raffaele | OTHER |
| Istituto Universitario di Studi Superiori Pavia | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRAGMACOM | Experimental | 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. |
|
| Standard Neuropsychological Treatment | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pragmatic Rehabilitation | Behavioral | A series of behavioral activities to improve specific pragmatic abilities in patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Healthy participants
Schizophrenia:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giorgio Arcara | Contact | 0412207594 | giorgio.arcara@hsancamillo.it | |
| Sonia Montemurro | Contact | sonia.montemurro@hsancamillo.it |
| Name | Affiliation | Role |
|---|---|---|
| Arcara | IRCCS San Camillo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Recruiting | Milan | MI | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35526293 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Neuropsychological Rehabilitation | Behavioral | A series of behavioral activities to improve general aspect of cognition, with a specific focus on attentional abilities. |
|
|
| 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) |
| IRCCS Eugenio Medea | Recruiting | Pieve di Soligo | TV | 31053 | Italy |
|
| Istituto Universitario di Studi Superiori Pavia | Recruiting | Pavia | Italy |
|
| IRCCS San Camillo Hospital | Recruiting | Venice | Italy |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |