A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931

Summary

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).

Conditions

• Primary Progressive Aphasia

Interventions

DEVICE

Active tDCS

Active tDCS (anode will be applied over the left DLPFC with the cathode over the right supraorbital region);

BEHAVIORAL

individualized language training

individualized language training

DEVICE

Placebo tDCS

Placebo tDCS (the current will be turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period);

Sponsors & Collaborators

• Fondazione Regionale per la Ricerca Biomedica

  collaborator OTHER

• Fondazione Mondino

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan

  collaborator UNKNOWN

• IRCCS Centro San Giovanni di Dio Fatebenefratelli

  lead OTHER

Principal Investigators

• Maria Cotelli · IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2026-01-31

Completion

2026-02-28

Countries

• Italy

Study Locations