Primary Progressive AphasiaMAINSTREAMNCT05730023
A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931
A study testing Active tDCS and individualized language training in people with Primary Progressive Aphasia, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Progressive Aphasia
- What is being tested?
- Active tDCS and individualized language training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Feb 2023to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
Maria Cotelli
Brescia, BS, 25125
Maria Cotelli, PhD, 00390303501457, mcotelli@fatebenefratelli.eu
- Recruiting
Tiziana Carandini
Milan, MI, 20122
Tiziana Carandini, MD, 00390255033814, tiziana.carandini@policlinico.mi.it
- Recruiting
Francesca Baglio
Milan, MI, 20148
Francesca Baglio, MD, 00390240308069, fbaglio@dongnocchi.it
- Recruiting
Stefano F. Cappa
Pavia, PV, 27100
Stefano Cappa, MD, 00390382380351, stefano.cappa@mondino.it
About this study
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).
Read the 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
- Being tested
- Active tDCS, individualized language training, Placebo tDCS
- Keywords
- Behavioral and neural effects of tDCS combined with language training, Alzheimer's disease and other dementias
- Medical subject headings
- Aphasia, Primary Progressive, Behavior, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Active tDCS (anode will be applied over the left DLPFC with the cathode over the right supraorbital region);
individualized language trainingBehavioural
individualized language training
Placebo tDCSDevice
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);
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: individualized language training; Device: Placebo tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Stroke and Aphasia Quality of Life Scale - 39 (SAQoL-39) is a measure of health-related quality of life in people with long-term aphasia. It provides a total score from 1 to 5 (higher score=better outcome) and it analyzes the following four domains: physical (score range: min= 1, max= 5, higher score=better outcome); psychosocial (score range: min= 1, max= 5, higher score=better outcome); communication (score range: min= 1, max= 5, higher score=better outcome) and energy (score range: min= 1, max= 5, higher score=better outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in measure of quality of life as assessed by Communication Outcome After Stroke (COAST)
Communication Outcome After Stroke (COAST) is a measure of the functional communication in daily activities and of the impact of the quality of life point of view of aphasia patient (COAST total score range: min= 0, max= 80, higher score=better outcome) and their carer (Carer COAST total score range: min= 0, max= 80, higher score=better outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in measure of quality of life as assessed by Functional Outcome Questionnaire-aphasia
Functional Outcome Questionnaire-aphasia is a measure of aphasia's functional and pragmatic communication in home and community settings, It provides a total score from 32 to 160 (higher score=better outcome) and it is divided into four subscales: communicating basic needs (CBN score range: min= 1, max= 35, higher score=better outcome); making routine requests (MRR score range: min= 1, max= 35, higher score=better outcome); communicating new information (CNI score range: min= 1, max= 40, higher score=better outcome) and attention/other communication skills (AO score range: min= 1, max= 50, higher score=better outcome).
Measured: 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
Frontotemporal Dementia- Clinical Dementia Rating Scale (FTD-CDR)- Sum of Boxes (score range: min= 0, max= 24, higher score=worse outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in dementia severity as assessed by Global Clinical Dementia Rating (CDR) plus NACC FTLD
Global Clinical Dementia Rating (CDR) plus NACC FTLD (score range: min= 0, max= 3, higher score=worse outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in aphasia severity as assessed by Progressive Aphasia Severity Scale (PASS)
PASS is a measure of severity and progression of language deficits in patients with PPA. The scale assesses ten linguistic domains (each score range: min= 0, max= 3): articulation (higher score=worse outcome), fluency (higher score=worse outcome), syntax and grammar (higher score=worse outcome), word retrieval and expression (higher score=worse outcome), repetition (higher score=worse outcome), auditory comprehension (higher score=worse outcome), single word comprehension (higher score=worse outcome), reading (higher score=worse outcome), writing (higher score=worse outcome) and functional communication (higher score=worse outcome). Moreover, it analyzes three supplemental domains (each score range: min= 0, max= 3): initiation of conversation (higher score=worse outcome), turn taking during conversation (higher score=worse outcome) and generation of language (higher score=worse outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in functional communication skills as assessed by Lincoln Speech Questionnaire
Lincoln Speech Questionnaire provides a speech score (score range: min= 0, max= 14, higher score=better outcome) and an understanding score (score range: min= 0, max= 5, higher score=better outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in aphasia severity as assessed by Communication Severity Rating Scale (Goodglass and Kaplan)
Communication Severity Rating Scale (Goodglass and Kaplan): score range: min= 0, max= 5, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in depressive symptoms as assessed by Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI): score range: min= 0, max= 63, higher score=worse outcome
Measured: Baseline up to 2 weeks and 3 months
Change in behavior and personality as assessed by Frontal Behavioral Inventory (FBI)
Frontal Behavioral Inventory (FBI): score range: min= 0, max= 72, higher score=worse outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of naming as assessed by Picture Naming subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Picture Naming subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 14, higher score=better outcome), living score (score range: min= 0, max= 7, higher score=better outcome) and non-living score (score range: min= 0, max= 7, higher score=better outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in measure of comprehension as assessed by Auditory sentence comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Auditory sentence comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND): total score range: min= 0, max= 8, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of comprehension as assessed by Single-word comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Single-word comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 12, higher score=better outcome), living score (score range: min= 0, max= 6, higher score=better outcome) and non-living score (score range: min= 0, max= 6, higher score=better outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in measure of repetition as assessed by Repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 10, higher score=better outcome), words score (score range: min= 0, max= 6, higher score=better outcome) and non-words score (score range: min= 0, max= 4, higher score=better outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in measure of repetition as assessed by Sentence repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Sentence repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 6, higher score=better outcome), predictable sentences score (score range: min= 0, max= 3, higher score=better outcome) and unpredictable sentences score (score range: min= 0, max= 3, higher score=better outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in measure of reading as assessed by Reading subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Reading subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides total score (score range: min= 0, max= 16, higher score=better outcome), words score (score range: min= 0, max= 12, higher score=better outcome) and non-words score (score range: min= 0, max= 4, higher score=better outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in measure of writing as assessed by Writing subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Writing subtest from Screening for Aphasia in NeuroDegeneration (SAND) provides Information Units score (score range: min= 0, max= 6, higher score=better outcome), total number of words score (score range: min= 0, max= no limits, higher score=better outcome), number of nouns/total number of words score (score range: min= 0, max= 1, higher score=better outcome), number of verbs/total number of words (score range: min= 0, max= 1, higher score=better outcome), number of correct syntactic structures/total number of syntactic structures score (score range: min= 0, max= 1, higher score=better outcome), number of orthographic errors score (score range: min= 0, max= no limits, higher score=worse outcome), number of lexico-semantic errors/number of words score (score range: min= 0, max= 1, higher score=worse outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in measure of semantics as assessed by Semantic association subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Semantic association subtest from Screening for Aphasia in NeuroDegeneration (SAND): total score range: min= 0, max= 4, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of oral production as assessed by Picture description subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Picture description subtest from SAND provides Information Units score (score range: min= 0, max= 8, higher score=better outcome), total number of words score (score range: min= 0, max= no limits, higher score=better outcome), number of nouns/total number of words score (score range: min= 0, max= 1, higher score=better outcome), number of verbs/total number of words score (score range: min= 0, max= 1, higher score=better outcome), number of sentences score (score range: min= 0, max= no limits, higher score=better outcome), number of subordinates/number of sentences score (score range: min= 0, max= no limits, higher score=better outcome), number of repaired sequences/number of words score (score range: min= 0, max= 1, higher score=worse outcome), number of phonological errors/number of words (score range: min= 0, max= 1, higher score=worse outcome), number of lexico-semantic errors/number of words (score range: min= 0, max= 1, higher score=worse outcome).
Measured: Baseline up to 2 weeks and 3 months
Change in measure of naming as assessed by Subtest from Aachener Aphasie Test (AAT)
Naming subtest from Aachener Aphasie Test (AAT): score range: min= 0, max= 120, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of object naming as assessed by Subtest from Battery for the Assessment of Aphasic Disorders (BADA)
Subtest from Battery for the Assessment of Aphasic Disorders (BADA): score range: min= 0, max= 30, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of fluency abilities as assessed by Verbal Fluency (semantic and phonemic)
Verbal Fluency (semantic and phonemic): score range min= 0, max= no limits, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of constructional praxia as assessed by Rey-Osterrieth Complex Figure-Copy
Rey-Osterrieth Complex Figure-Copy: score range min= 0, max= 36, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of verbal long-term memory as assessed by Story Recall
Story Recall: score range min= 0, max= 28, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of nonverbal long-term memory as assessed by Rey-Osterrieth Complex Figure-Recall
Rey-Osterrieth Complex Figure-Recall: score range min= 0, max= 36, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of attentional abilities as assessed by Trial Making Test
Trial Making Test: score range: min= n/a, max= no limits, higher score=worse outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of executive abilities as assessed by Stroop Test
Stroop Test: score range: min= n/a, max= no limits, higher score=worse outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in measure of global cognitive impairment as assessed by Mini Mental State Examination (MMSE)
Mini Mental State Examination (MMSE): score range: min= 0, max= 30, higher score=better outcome.
Measured: Baseline up to 2 weeks and 3 months
Change in molecular biomarkers as assessed by the size and the concentration of plasma Extracellular vesicles (EVs)
Size and the concentration of plasma EVs
Measured: Baseline up to 2 weeks
Change in molecular biomarkers as assessed by Neurofilament light chain (NFL) levels
Neurofilament light chain (NFL) levels
Measured: Baseline up to 2 weeks
Change in molecular biomarkers as assessed by Glial Fibrillary Acidic Protein (GFAP) levels
Glial Fibrillary Acidic Protein (GFAP) levels
Measured: Baseline up to 2 weeks
Change in molecular biomarkers as assessed by brain-derived neurotrophic factor (BDNF)
Brain-derived neurotrophic factor (BDNF) levels
Measured: Baseline up to 2 weeks
Change in molecular biomarkers as assessed by neurogranin levels
Neurogranin levels
Measured: Baseline up to 2 weeks
Change in functional connectivity as derived from resting-state functional MRI
Functional connectivity as derived from resting-state functional MRI
Measured: Baseline up to 2 weeks
Change in structural connectivity as derived from diffusion-weighted MRI
Structural connectivity as derived from diffusion-weighted MRI
Measured: Baseline up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Feb 2023
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Progressive AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Regionale per la Ricerca Biomedica, IRCCS National Neurological Institute "C. Mondino" Foundation, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan
- Responsible party
- Sponsor
- Investigators
- Maria Cotelli, Principal investigator, IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730023
- Sponsor's protocol ID
- MAINSTREAM ID:3430931
- Acronym
- MAINSTREAM
- Status last verified
- Sep 2024
- First submitted
- 31 Jan 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37508992
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931
- ClinicalTrials.gov ID
- NCT05730023
- Acronym / sponsor ID
- MAINSTREAM / MAINSTREAM ID:3430931
- Conditions
- Primary Progressive Aphasia
- Keywords
- Behavioral and neural effects of tDCS combined with language training, Alzheimer's disease and other dementias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Collaborators
- Fondazione Regionale per la Ricerca Biomedica, IRCCS National Neurological Institute "C. Mondino" Foundation, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, IRCCS Fondazione Don Carlo Gnocchi - ONLUS, Milan
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS plus individualized language training | Experimental | Device: Active tDCS, Behavioral: individualized language trainingThe group will receive five consecutive days a week for two weeks of 25 minutes sessions of Active tDCS combined with an individualized language training |
| Placebo tDCS plus individualized language training | Active comparator | Behavioral: individualized language training, Device: Placebo tDCSThe group will receive five consecutive days a week for two weeks of 25 minutes sessions of Placebo tDCS combined with an individualized language training |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSActive tDCS (anode will be applied over the left DLPFC with the cathode over the right supraorbital region); | Device | Active tDCS plus individualized language training |
| individualized language trainingindividualized language training | Behavioural | Active tDCS plus individualized language training, Placebo tDCS plus individualized language training |
| Placebo tDCSPlacebo tDCS (the current will be turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period); | Device | Placebo tDCS plus individualized language training |
Primary outcome
Change in measure of naming as assessed by International Picture Naming Project Task (IPNP)
Time frame: Baseline up to 2 weeks and 3 months
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).
35 secondary outcomes
Change in measure of quality of life as assessed by Stroke and Aphasia Quality of Life Scale - 39 (SAQoL-39)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of quality of life as assessed by Communication Outcome After Stroke (COAST)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of quality of life as assessed by Functional Outcome Questionnaire-aphasia
Time frame: 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
Time frame: Baseline up to 2 weeks and 3 months
Change in dementia severity as assessed by Global Clinical Dementia Rating (CDR) plus NACC FTLD
Time frame: Baseline up to 2 weeks and 3 months
Change in aphasia severity as assessed by Progressive Aphasia Severity Scale (PASS)
Time frame: Baseline up to 2 weeks and 3 months
Change in functional communication skills as assessed by Lincoln Speech Questionnaire
Time frame: Baseline up to 2 weeks and 3 months
Change in aphasia severity as assessed by Communication Severity Rating Scale (Goodglass and Kaplan)
Time frame: Baseline up to 2 weeks and 3 months
Change in depressive symptoms as assessed by Beck Depression Inventory (BDI)
Time frame: Baseline up to 2 weeks and 3 months
Change in behavior and personality as assessed by Frontal Behavioral Inventory (FBI)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of naming as assessed by Picture Naming subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of comprehension as assessed by Auditory sentence comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of comprehension as assessed by Single-word comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of repetition as assessed by Repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of repetition as assessed by Sentence repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of reading as assessed by Reading subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of writing as assessed by Writing subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of semantics as assessed by Semantic association subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of oral production as assessed by Picture description subtest from Screening for Aphasia in NeuroDegeneration (SAND)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of naming as assessed by Subtest from Aachener Aphasie Test (AAT)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of object naming as assessed by Subtest from Battery for the Assessment of Aphasic Disorders (BADA)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of fluency abilities as assessed by Verbal Fluency (semantic and phonemic)
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of constructional praxia as assessed by Rey-Osterrieth Complex Figure-Copy
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of verbal long-term memory as assessed by Story Recall
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of nonverbal long-term memory as assessed by Rey-Osterrieth Complex Figure-Recall
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of attentional abilities as assessed by Trial Making Test
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of executive abilities as assessed by Stroop Test
Time frame: Baseline up to 2 weeks and 3 months
Change in measure of global cognitive impairment as assessed by Mini Mental State Examination (MMSE)
Time frame: Baseline up to 2 weeks and 3 months
Change in molecular biomarkers as assessed by the size and the concentration of plasma Extracellular vesicles (EVs)
Time frame: Baseline up to 2 weeks
Change in molecular biomarkers as assessed by Neurofilament light chain (NFL) levels
Time frame: Baseline up to 2 weeks
Change in molecular biomarkers as assessed by Glial Fibrillary Acidic Protein (GFAP) levels
Time frame: Baseline up to 2 weeks
Change in molecular biomarkers as assessed by brain-derived neurotrophic factor (BDNF)
Time frame: Baseline up to 2 weeks
Change in molecular biomarkers as assessed by neurogranin levels
Time frame: Baseline up to 2 weeks
Change in functional connectivity as derived from resting-state functional MRI
Time frame: Baseline up to 2 weeks
Change in structural connectivity as derived from diffusion-weighted MRI
Time frame: Baseline up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 37508992Cotelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Cotelli principal investigator
IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS and individualized language training in people with Primary Progressive Aphasia, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Cotelli (00390303501457, mcotelli@fatebenefratelli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measure of naming as assessed by International Picture Naming Project Task (IPNP) (time frame: Baseline up to 2 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.