Schizophrenia, Stroke, Traumatic Brain Injury
Conditions
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.
Interventions
BEHAVIORALPragmatic Rehabilitation
A series of behavioral activities to improve specific pragmatic abilities in patients
BEHAVIORALNeuropsychological Rehabilitation
A series of behavioral activities to improve general aspect of cognition, with a specific focus on attentional abilities.
Sponsors
IRCCS San Raffaele
Istituto Universitario di Studi Superiori Pavia
IRCCS San Camillo, Venezia, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in APACS-Brief scores (Assessment of Pragmatic Abilities and Cognitive Substrates - Brief). | 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) | A short test on pragmatic abilities. Scores range from 0 to 1. Higher values indicates better score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
| 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) | 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) |
Countries
Italy
Contacts
Primary ContactGiorgio Arcara
Backup ContactSonia Montemurro
Outcome results
None listed