Primary progressive aphasia
Conditions
Interventions
Group 1: Intervention: Intensive speech-language teletherapy (naming training and communicative-pragmatic therapy) combined with home-based tDCS (active stimulation), 12 sessions of two hours (one ho
Sponsors
Universitätsmedizin Greifswald, Klinik- und Poliklinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosis of PPA (clinical imaging-supported diagnosis according to the German S3 Dementia Guideline, additionally reviewed and verified by study physician) - Absence of contraindications for tDCS (confirmed by a physician) - Mild to moderate language impairment - Availability of a family member or caregiver willing to provide on-site support throughout the study, particularly during the intervention phase - Stable internet connection at home
Exclusion criteria
Exclusion criteria: - Standard exclusion criteria for tDCS, including: cardiac pacemaker, metallic implants in the brain or head region (e.g., metal plates, screws/clips in the skull), current epilepsy or a family history of epilepsy, skin lesions, acute inflammation, or dermatological conditions (e.g., psoriasis) in the areas of the head where electrodes are placed (Antal et al., 2017; 2025) - < 80 errors in the standardized naming test (Meinzer et al., 2016) during the baseline assessments - Current psychiatric, psychological, or neurological disorders at the time of assessment according to the patient record - History of post-stroke aphasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: (a) at least 80 % of all randomized patients complete = 75 % (= 3 sessions/week) of the planned speech-language teletherapy and home-based tDCS and (b) at least 80 % of the randomized patients complete = 90 % of protocol steps, as measured by daily competency checklists. Patient-reported outcomes: patient-reported impact of the intervention on naming ability and everyday life communication, assessed using 7-point Likert scales for each outcome with values from -3 to +3. Each Likert scale offers the option to rate if respondents perceive the intervention as beneficial (+3, +2, +1) or not (-3, -2, -1), as well as the extent of the perceived improvement or deterioration (+/-1 = mild, +/-2 = moderate, +/-3 = strong improvement/deterioration), with 0 representing no perceived change. The determination of the threshold for each Likert scale is carried out through consensus ratings by patients and caregivers during the baseline assessments and will serve as anchor points for developing benchmarks corresponding to clinically meaningful treatment outcomes in the sense of a minimal clinically relevant change (Minimal Important Change Benchmark). Time point: immediately after the intervention (primary outcome) and after 3 months (secondary outcome) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability: Adverse events assessed using established questionnaires (standard tDCS questionnaire, Antal et al., 2017) and rating scales (Wong-Baker Faces Pain Rating Scale; Fatigue Scale, Pierce et al., 2024), recorded daily after each speech-language teletherapy session during the intervention period. Blinding: Blinding of patients and their caregivers regarding tDCS condition (active or sham stimulation), assessed using a questionnaire after completion of the intervention period. Patient-reported outcomes: patient-reported impact of speech-language teletherapy combined with home-based tDCS on overall language ability, psychological well-being, health-related quality of life, and social participation, assessed using 7-point Likert scales (analogous to the primary endpoint), after completion of the intervention period and after 3 months. Acceptability and satisfaction: Acceptability of and satisfaction with the intervention among patients and caregivers, assessed through semi-structured interviews after completion of the intervention period and and after 3 months. Specific treatment effect on naming: Improvements in naming performance assessed using a naming test consisting of 40 trained items and 40 untrained items, after completion of the intervention period and and after 3 months. General language ability and (non-)verbal communication: Language and communication abilities assessed using a selection of standardized tests (general language ability: semantic/phonemic verbal fluency, Boston Naming Test, Digit Span Test, Token Test, written language subtest of the Aachen Aphasia Test (AAT), Cookie Theft picture description task; (non-)verbal communication ability: Scenario Test, Communication Effectiveness in Everyday Life Inventory (CETI)). | — |
Countries
Germany
Contacts
Public ContactAnna Rysop
Universitätsmedizin Greifswald, Klinik- und Poliklinik für Neurologie
Outcome results
None listed