A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931
NCT05730023, Not applicable, Unknown, IRCCS Centro San Giovanni di Dio Fatebenefratelli
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Multimodal Approach for Clinical Diagnosis and Treatment of Primary Progressive Aphasia, MAINSTREAM ID:3430931 | ClinicalTrials.gov |
| NCT number | NCT05730023 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli | ClinicalTrials.gov |
| Conditions | Primary Progressive Aphasia | ClinicalTrials.gov |
| Interventions | Active tDCS, individualized language training, Placebo tDCS | ClinicalTrials.gov |
| First posted | 2023-02-15 | ClinicalTrials.gov |
| Last updated | 2024-09-19 | ClinicalTrials.gov |
Registered outcomes 36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in measure of naming as assessed by International Picture Naming Project Task (IPNP) | 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). | ClinicalTrials.gov |
| Secondary | 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 | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of quality of life as assessed by Communication Outcome After Stroke (COAST) | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of quality of life as assessed by Functional Outcome Questionnaire-aphasia | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | 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 | Frontotemporal Dementia- Clinical Dementia Rating Scale (FTD-CDR)- Sum of Boxes (score range: min= 0, max= 24, higher score=worse outcome). | ClinicalTrials.gov |
| Secondary | Change in dementia severity as assessed by Global Clinical Dementia Rating (CDR) plus NACC FTLD | Baseline up to 2 weeks and 3 months | Global Clinical Dementia Rating (CDR) plus NACC FTLD (score range: min= 0, max= 3, higher score=worse outcome). | ClinicalTrials.gov |
| Secondary | Change in aphasia severity as assessed by Progressive Aphasia Severity Scale (PASS) | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in functional communication skills as assessed by Lincoln Speech Questionnaire | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in aphasia severity as assessed by Communication Severity Rating Scale (Goodglass and Kaplan) | Baseline up to 2 weeks and 3 months | Communication Severity Rating Scale (Goodglass and Kaplan): score range: min= 0, max= 5, higher score=better outcome. | ClinicalTrials.gov |
| Secondary | Change in depressive symptoms as assessed by Beck Depression Inventory (BDI) | Baseline up to 2 weeks and 3 months | Beck Depression Inventory (BDI): score range: min= 0, max= 63, higher score=worse outcome | ClinicalTrials.gov |
| Secondary | Change in behavior and personality as assessed by Frontal Behavioral Inventory (FBI) | Baseline up to 2 weeks and 3 months | Frontal Behavioral Inventory (FBI): score range: min= 0, max= 72, higher score=worse outcome. | ClinicalTrials.gov |
| Secondary | Change in measure of naming as assessed by Picture Naming subtest from Screening for Aphasia in NeuroDegeneration (SAND) | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of comprehension as assessed by Auditory sentence comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND) | Baseline up to 2 weeks and 3 months | Auditory sentence comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND): total score range: min= 0, max= 8, higher score=better outcome. | ClinicalTrials.gov |
| Secondary | Change in measure of comprehension as assessed by Single-word comprehension subtest from Screening for Aphasia in NeuroDegeneration (SAND) | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of repetition as assessed by Repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND) | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of repetition as assessed by Sentence repetition subtest from Screening for Aphasia in NeuroDegeneration (SAND) | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of reading as assessed by Reading subtest from Screening for Aphasia in NeuroDegeneration (SAND) | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of writing as assessed by Writing subtest from Screening for Aphasia in NeuroDegeneration (SAND) | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of semantics as assessed by Semantic association subtest from Screening for Aphasia in NeuroDegeneration (SAND) | Baseline up to 2 weeks and 3 months | Semantic association subtest from Screening for Aphasia in NeuroDegeneration (SAND): total score range: min= 0, max= 4, higher score=better outcome. | ClinicalTrials.gov |
| Secondary | Change in measure of oral production as assessed by Picture description subtest from Screening for Aphasia in NeuroDegeneration (SAND) | Baseline up to 2 weeks and 3 months | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 37508992 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Picture Naming Test | Primary outcome | ConductCognition |
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)