Actively Recruiting
A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931
Led by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Updated on 2024-09-19
60
Participants Needed
4
Research Sites
156 weeks
Total Duration
On this page
Sponsors
I
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Lead Sponsor
F
Fondazione Regionale per la Ricerca Biomedica
Collaborating Sponsor
AI-Summary
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).
CONDITIONS
Official Title
A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Primary Progressive Aphasia according to current clinical criteria
- Mild Primary Progressive Aphasia defined by the Progressive Aphasia Severity Scale (PASS)
- Italian native speaker
You will not qualify if you...
- Presence of developmental disorders
- Any medical or psychiatric illness that could interfere with completing assessments
- Any medical condition that is a contraindication to transcranial direct current stimulation (tDCS)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Maria Cotelli
Brescia, BS, Italy, 25125
Actively Recruiting
2
Tiziana Carandini
Milan, MI, Italy, 20122
Actively Recruiting
3
Francesca Baglio
Milan, MI, Italy, 20148
Actively Recruiting
4
Stefano F. Cappa
Pavia, PV, Italy, 27100
Actively Recruiting
Research Team
M
Maria Cotelli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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