A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931
Recruiting · NCT05730023 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
4 locations listed.
- Maria Cotelli - Brescia, BS, Italy
- Tiziana Carandini - Milan, MI, Italy
- Francesca Baglio - Milan, MI, Italy
- Stefano F. Cappa - Pavia, PV, Italy