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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Maria Cotelli
RECRUITING
Brescia
Francesca Baglio
RECRUITING
Milan
Tiziana Carandini
RECRUITING
Milan
Stefano F. Cappa
RECRUITING
Pavia
Contact Information
Primary
Maria Cotelli
mcotelli@fatebenefratelli.eu
00390303501457
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2026-02
Participants
Target number of participants: 60
Treatments
Experimental: Active tDCS plus individualized language training
The group will receive five consecutive days a week for two weeks of 25 minutes sessions of Active tDCS combined with an individualized language training
Active_comparator: Placebo tDCS plus individualized language training
The group will receive five consecutive days a week for two weeks of 25 minutes sessions of Placebo tDCS combined with an individualized language training
Related Therapeutic Areas
Sponsors
Collaborators: Fondazione Regionale per la Ricerca Biomedica, Fondazione Mondino, IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Leads: IRCCS Centro San Giovanni di Dio Fatebenefratelli

This content was sourced from clinicaltrials.gov