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

NCT05730023 | Recruiting

• 1 other identifier: MAINSTREAM ID:3430931
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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).

Conditions

Primary Progressive Aphasia

Keywords

Behavioral and neural effects of tDCS combined with language training; Alzheimer's disease and other dementias

Outcome Measures

Primary Outcomes (1)

• Change in measure of naming as assessed by International Picture Naming Project Task (IPNP)

  International Picture Naming Project Task (IPNP): trained (score range: min= 0, max= 32, higher score=better outcome) and untrained object items (score range: min= 0, max= 32, higher score=better outcome); action items (score range: min= 0, max= 60, higher score=better outcome).

  Baseline up to 2 weeks and 3 months

Secondary Outcomes (35)

• Change in measure of quality of life as assessed by Stroke and Aphasia Quality of Life Scale - 39 (SAQoL-39)

  Baseline up to 2 weeks and 3 months

• Change in measure of quality of life as assessed by Communication Outcome After Stroke (COAST)

  Baseline up to 2 weeks and 3 months

• Change in measure of quality of life as assessed by Functional Outcome Questionnaire-aphasia

  Baseline up to 2 weeks and 3 months

• Change in dementia severity as assessed by Frontotemporal Dementia- Clinical Dementia Rating Scale (FTD-CDR)- Sum of Boxes

  Baseline up to 2 weeks and 3 months

• Change in dementia severity as assessed by Global Clinical Dementia Rating (CDR) plus NACC FTLD

  Baseline up to 2 weeks and 3 months

Study Arms (2)

Active tDCS plus individualized language training

EXPERIMENTAL

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

Device: Active tDCS; Behavioral: individualized language training

Placebo tDCS plus individualized language training

ACTIVE COMPARATOR

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

Behavioral: individualized language training; Device: Placebo tDCS

Interventions

Active tDCS DEVICE

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

Active tDCS plus individualized language training

individualized language training BEHAVIORAL

individualized language training

Active tDCS plus individualized language training; Placebo tDCS plus individualized language training

Placebo tDCS 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);

Placebo tDCS plus individualized language training

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead
• Fondazione Regionale per la Ricerca Biomedica: collaborator
• Fondazione Mondino: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan: collaborator

Study Sites (4)

Maria Cotelli

Brescia, BS, 25125, Italy

RECRUITING

Tiziana Carandini

Milan, MI, 20122, Italy

RECRUITING

Francesca Baglio

Milan, MI, 20148, Italy

RECRUITING

Stefano F. Cappa

Pavia, PV, 27100, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 37508992 DERIVED

MeSH Terms

Conditions

Aphasia, Primary Progressive; Behavior; Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Maria Cotelli

  IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cotelli

CONTACT

00390303501457; mcotelli@fatebenefratelli.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 15, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)