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Pragmatic Assessment and Treatment for the Health System (PATHS)

Primary Purpose

Stroke, Traumatic Brain Injury, Schizophrenia

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pragmatic Rehabilitation
Neuropsychological Rehabilitation
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IRCCS San RaffaeleRecruiting
  • Istituto Universitario di Studi Superiori PaviaRecruiting
  • IRCCS San Camillo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRAGMACOM

Standard Neuropsychological Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)

Full Information

First Posted
March 2, 2023
Last Updated
March 30, 2023
Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
IRCCS San Raffaele, Istituto Universitario di Studi Superiori Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT05809401
Brief Title
Pragmatic Assessment and Treatment for the Health System
Acronym
PATHS
Official Title
"Assessment and Treatment of Communicative Pragmatic Abilities in Neurological and Psychiatric Disorders: Feasibility and Clinical Efficacy (PATHS)"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
IRCCS San Raffaele, Istituto Universitario di Studi Superiori Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Traumatic Brain Injury, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRAGMACOM
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Neuropsychological Treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pragmatic Rehabilitation
Other Intervention Name(s)
Pragmatic language Rehabilitation
Intervention Description
A series of behavioral activities to improve specific pragmatic abilities in patients
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological Rehabilitation
Other Intervention Name(s)
Cognitive Rehabilitation
Intervention Description
A series of behavioral activities to improve general aspect of cognition, with a specific focus on attentional abilities.
Primary Outcome Measure Information:
Title
Change in APACS-Brief scores (Assessment of Pragmatic Abilities and Cognitive Substrates - Brief).
Description
A short test on pragmatic abilities. Scores range from 0 to 1. Higher values indicates better score
Time Frame
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 Outcome Measure Information:
Title
Change in EEG (Electroencephalography) activity - ASSR (Auditory Steady State Response)
Description
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)
Time Frame
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)
Title
Change in EEG (Electroencephalography) activity - MMN (Mismatch Negativity)
Description
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)
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giorgio Arcara
Phone
0412207594
Email
giorgio.arcara@hsancamillo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Montemurro
Email
sonia.montemurro@hsancamillo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arcara
Organizational Affiliation
IRCCS San Camillo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Raffaele
City
Milano
State/Province
MI
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Bosia
Email
bosia.marta@hsr.it
Facility Name
Istituto Universitario di Studi Superiori Pavia
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Bambini
Email
valentina.bambini@iusspavia.it
Facility Name
IRCCS San Camillo Hospital
City
Venice
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Camparini
Email
n.ricercaclinica@hsancamillo.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35526293
Citation
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.
Results Reference
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Pragmatic Assessment and Treatment for the Health System

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