Table 1.
Testing.
| Study procedure | Pre-screening | Screening | Baseline | Treatment | Post-treatment | 6-month follow-up | 12-month follow-up |
|---|---|---|---|---|---|---|---|
| Visit number | T0 | T1 | T2 | T3 | |||
| Place | Clinic | Clinic/patients' home | Clinic/patients' home | Clinic | Clinic/patients' home | Clinic/patients' home | Clinic/patients' home |
| Study month | 0 | Week 1–3 | 1 | 6 | 12 | ||
| Informed consent | • | ||||||
| In- and exclusion criteria (chart-based) | • | ||||||
| In- and exclusion criteria (study-specific) | • | ||||||
| Demographics and medical history | • | ||||||
| Prior and current treatment | • | ||||||
| Vital signs | • | ||||||
| Physical examination | • | ||||||
| Magnetic resonance imaging | • | ||||||
| Aachen Aphasia Test | • | • | |||||
| Hierarchical Word Lists | • | ||||||
| Corsi Block-Tapping Task | • | ||||||
| Amsterdam Nijmegen Everyday Language Test | • | • | • | • | |||
| Naming ability | • | • | • | • | |||
| Communicative- Pragmatic Screening | • | ||||||
| Scenario Test | • | • | |||||
| Communicative Effectiveness Index | • | • | • | • | |||
| NeuroCogFX | • | • | |||||
| Benton Visual Retention Test | • | • | |||||
| SADQH-10 | • | • | • | • | |||
| SAQOL-39g | • | • | • | • | |||
| EQ-5D-5L and EQ-5D-VAS | • | • | • | • | |||
| Patient Resource Consumption Questionnaire | • | • | • | ||||
| Burden of informal caregivers | • | • | • | • | |||
| tDCS Safety Questionnaire | • | • | • | • | • | ||
| Minimal Important Difference | • | • | • |
Selected linguistic functions, Aachen Aphasia Test (13); Apraxia of speech, Hierarchical Word Lists (14); Non-verbal working memory, Corsi Block-Tapping Task (15); Communication ability (primary outcome), Amsterdam Nijmegen Everyday Language Test (A-scale; parallel versions used in counterbalanced order across participants) (6); Naming ability, personally relevant trained and untrained items, consistent with previous work (12); (Non-)verbal communication, Communicative-Pragmatic Screening (18), Scenario Test (Nobis-Bosch et al. in preparation), and Communicative Effectiveness Index (20); Attention and executive function, reaction-speed subscales from NeuroCogFX (21); Non-verbal episodic memory, Figure Recognition Task from Benton Visual Retention Test (22); Mood, German version of the 10-item Stroke Aphasic Depression Questionnaire (SADQH-10) (23); Health-related quality of life, SAQOL-39g (24); EQ-5D-5L and EQ-5D-VAS (25); Health economic evaluation: direct and indirect costs during the 12-month study period (determined by the self-developed Patient Resource Consumption Questionnaire and based on common standardized unit cost assumptions), and Quality-Adjusted Life Years (derived from the EQ-5D-5L data) (26); Unpaid support provided by family members or friends, Burden of informal caregivers (27); (Serious) adverse events, tDCS Safety Questionnaire (28); Subjective treatment-induced change, as experienced by patients, therapists, and relatives, Minimal Important Difference (29).