Primary Progressive Aphasia (PPA) is a syndrome due to different neurodegenerative disorders selectively disrupting language functions. PPA specialist care is underdeveloped. There are very few specialists (neurologists, psychiatrists, neuropsychologists and speech therapists) and few hospitals- or community-based services dedicated to diagnosis and continuing care. Currently, healthcare systems struggle to provide adequate coverage of diagnostic services, and care is too often fragmented, uncoordinated, and unresponsive to the needs of people with PPA and their families. Recently attention has been gained by digital-health technologies, such immunoassay analyzer and high-field MRI, the most promising approaches to increase our understanding of neurodegeneration, and by new non-invasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) that allow a personalized treatment approach. Our goal is to develop a new treatment approach in PPA in which the regional secondary care centers participating in this project should be the hub of a regional network. The MAINSTREAM (WP2- Efficacy of personalized training in the early stage of PPA) looks forward to introduce and evaluate therapeutic innovation such as tDCS coupled with language therapy in rehabilitation settings (WP2 Early Treatment).
This objective will be pursued by conducting a randomized controlled pilot study in order to evaluate the efficacy of a combined treatment of Active (anodal) tDCS and individualized language training compared to Placebo tDCS combined with individualized language training in a subgroup of mild PPA defined using the Progressive Aphasia Severity Scale (PASS) (Sapolsky D, Domoto-Reilly K, Dickerson BCJA. Use of the Progressive Aphasia Severity Scale (PASS) in Monitoring Speech and Language Status in PPA. (2014) 28(8-9):993-1003).
Diagnosis PPA according to the current clinical criteria (Gorno-Tempini et al., 2011);
Mild PPA defined using the Progressive Aphasia Severity Scale (PASS);
Italian native speakers.
Presence of developmental disorders;
Presence of any medical or psychiatric illness that could interfere in completing assessments;
Presence of any medical condition that represents a contraindication to tDCS.
Parallel
Active tDCS
DeviceActive tDCS (anode will be applied over the left DLPFC with the cathode over the right supraorbital region);
individualized language training
Behavioralindividualized language training
Placebo tDCS
DevicePlacebo tDCS (the current will be turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period);
Change in measure of naming as assessed by International Picture Naming Project Task (IPNP)
International Picture Naming Project Task (IPNP): trained (score range: min= 0, max= 32, higher score=better outcome) and untrained object items (score range: min= 0, max= 32, higher score=better outcome); action items (score range: min= 0, max= 60, higher score=better outcome).
Change in measure of quality of life as assessed by Stroke and Aphasia Quality of Life Scale - 39 (SAQoL-39)
Stroke and Aphasia Quality of Life Scale - 39 (SAQoL-39) is a measure of health-related quality of life in people with long-term aphasia. It provides a total score from 1 to 5 (higher score=better outcome) and it analyzes the following four domains: physical (score range: min= 1, max= 5, higher score=better outcome); psychosocial (score range: min= 1, max= 5, higher score=better outcome); communication (score range: min= 1, max= 5, higher score=better outcome) and energy (score range: min= 1, max= 5, higher score=better outcome).
Change in measure of quality of life as assessed by Communication Outcome After Stroke (COAST)
Communication Outcome After Stroke (COAST) is a measure of the functional communication in daily activities and of the impact of the quality of life point of view of aphasia patient (COAST total score range: min= 0, max= 80, higher score=better outcome) and their carer (Carer COAST total score range: min= 0, max= 80, higher score=better outcome).
Change in measure of quality of life as assessed by Functional Outcome Questionnaire-aphasia
Functional Outcome Questionnaire-aphasia is a measure of aphasia's functional and pragmatic communication in home and community settings, It provides a total score from 32 to 160 (higher score=better outcome) and it is divided into four subscales: communicating basic needs (CBN score range: min= 1, max= 35, higher score=better outcome); making routine requests (MRR score range: min= 1, max= 35, higher score=better outcome); communicating new information (CNI score range: min= 1, max= 40, higher score=better outcome) and attention/other communication skills (AO score range: min= 1, max= 50, higher score=better outcome).
Change in dementia severity as assessed by Frontotemporal Dementia- Clinical Dementia Rating Scale (FTD-CDR)- Sum of Boxes
Frontotemporal Dementia- Clinical Dementia Rating Scale (FTD-CDR)- Sum of Boxes (score range: min= 0, max= 24, higher score=worse outcome).
Click on the lead sponsor to view all of their trials.
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Lead sponsor
Fondazione Regionale per la Ricerca Biomedica
Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborator
IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan
Collaborator
