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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Primary Progressive Aphasia

In brief

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).

Key facts

Study ID

NCT05730023

Run by

IRCCS Centro San Giovanni di Dio Fatebenefratelli

People needed

60

Starts

2023-02-01

Expected to finish

2026-02-01

Last updated by the study team

2024-09-19

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Maria Cotelli — Brescia, BS, Italy (enrolling)
• Tiziana Carandini — Milan, MI, Italy (enrolling)
• Francesca Baglio — Milan, MI, Italy (enrolling)
• Stefano F. Cappa — Pavia, PV, Italy (enrolling)

Full record on ClinicalTrials.gov

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