Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05809401
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-03-02
Brief Title:
Pragmatic Assessment and Treatment for the Health System
Sponsor:
IRCCS San Camillo Venezia Italy
Organization:
IRCCS San Camillo Venezia Italy
Study Overview
Official Title:
Assessment and Treatment of Communicative Pragmatic Abilities in Neurological and Psychiatric Disorders Feasibility and Clinical Efficacy PATHS
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATHS
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None