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

NCT ID: NCT05730023

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-02-28

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).

Detailed Description

60 patients with PPA will be recruited from IRCCS Istituto Centro San Giovanni di Dio, Fatebenefratelli, Brescia; IRCCS Fondazione Istituto Neurologico Nazionale C. Mondino, Pavia; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan and Fondazione Don Carlo Gnocchi - ONLUS, Milan.

The diagnostic evaluation will include cognitive and language testing, neurologic examination and neuroimaging (Magnetic Resonance Imaging (MRI) or Positron Emission Tomography PET)).

All the patients will undergo five consecutive days a week for two weeks of treatment sessions of 25 minutes:

• 30 patients will receive Active tDCS over dorsolateral prefrontal cortex-DLPFC (anode over the left DLPFC with the cathode over the right supraorbital region) while performing an individualized language training;
• 30 patients will receive Placebo tDCS during an individualized language training.

The two groups will be matched for sex, age, education, language severity (as defined in the Frontotemporal Dementia Clinical Dementia Rating subscale), and overall severity according to the FTD Clinical Dementia Rating.

Two trained neuropsychologists will administer the neuropsychological testing at baseline (T0), post-treatment (T1) and 3-months (T2) follow-up. All of assessments will be conducted by the same assessor.

To elucidate the mechanisms underlying tDCS effects, Magnetic Resonance Imaging (MRI) and bimolecular data will be collected at T0 and T1 (after the treatment).

Conditions

Primary Progressive Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS plus individualized language training

The group will receive five consecutive days a week for two weeks of 25 minutes sessions of Active tDCS combined with an individualized language training

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: DEVICE

Active tDCS (anode will be applied over the left DLPFC with the cathode over the right supraorbital region);

individualized language training

Intervention Type: BEHAVIORAL

individualized language training

Placebo tDCS plus individualized language training

The group will receive five consecutive days a week for two weeks of 25 minutes sessions of Placebo tDCS combined with an individualized language training

Group Type: ACTIVE_COMPARATOR

individualized language training

Intervention Type: BEHAVIORAL

individualized language training

Placebo tDCS

Intervention Type: DEVICE

Placebo tDCS (the current will be turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period);

Interventions

Active tDCS

Active tDCS (anode will be applied over the left DLPFC with the cathode over the right supraorbital region);

Intervention Type: DEVICE

individualized language training

individualized language training

Intervention Type: BEHAVIORAL

Placebo tDCS

Placebo tDCS (the current will be turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period);

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Regionale per la Ricerca Biomedica

OTHER

Sponsor Role: collaborator

Fondazione Mondino

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: collaborator

IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan

UNKNOWN

Sponsor Role: collaborator

IRCCS Centro San Giovanni di Dio Fatebenefratelli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Cotelli

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli

Locations

Maria Cotelli

Brescia, BS, Italy

Site Status: RECRUITING

Tiziana Carandini

Milan, MI, Italy

Site Status: RECRUITING

Francesca Baglio

Milan, MI, Italy

Site Status: RECRUITING

Stefano F. Cappa

Pavia, PV, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Cotelli

Role: CONTACT

mcotelli@fatebenefratelli.eu

00390303501457

Facility Contacts

Maria Cotelli, PhD

Role: primary

mcotelli@fatebenefratelli.eu

00390303501457

Tiziana Carandini, MD

Role: primary

tiziana.carandini@policlinico.mi.it

00390255033814

Francesca Baglio, MD

Role: primary

fbaglio@dongnocchi.it

00390240308069

Stefano Cappa, MD

Role: primary

stefano.cappa@mondino.it

00390382380351

References

Cotelli M, Baglio F, Manenti R, Blasi V, Galimberti D, Gobbi E, Pagnoni I, Rossetto F, Rotondo E, Esposito V, De Icco R, Giudice C, Tassorelli C, Catricala E, Perini G, Alaimo C, Campana E, Benussi L, Ghidoni R, Binetti G, Carandini T, Cappa SF. A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia (MAINSTREAM): A Study Protocol. Brain Sci. 2023 Jul 12;13(7):1060. doi: 10.3390/brainsci13071060.

Reference Type: DERIVED

PMID: 37508992 (View on PubMed)

Other Identifiers

MAINSTREAM ID:3430931

Identifier Type: -

Identifier Source: org_study_id