Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT05730023

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

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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