NCT05730023 A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931
| NCT ID | NCT05730023 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli |
| Condition | Primary Progressive Aphasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-02-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Maria Cotelli
PRINCIPAL INVESTIGATOR
IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli
Frequently Asked Questions
Who can join the NCT05730023 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Primary Progressive Aphasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05730023 currently recruiting?
Yes, NCT05730023 is actively recruiting participants. Contact the research team at mcotelli@fatebenefratelli.eu for enrollment information.
Where is the NCT05730023 trial being conducted?
This trial is being conducted at Brescia, Italy, Milan, Italy, Milan, Italy, Pavia, Italy.
Who is sponsoring the NCT05730023 clinical trial?
NCT05730023 is sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. The principal investigator is Maria Cotelli at IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli. The trial plans to enroll 60 participants.