Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT04318951
Eligibility Criteria:
Inclusion Criteria:
* Left-hemisphere cortical or subcortical stroke;
* Native speaker of German;
* Right-handedness according to the Edinburgh Handedness Inventory (Oldfield, 1971);
* Diagnosis of post-stroke depression, as defined in the International Statistical Classification of Diseases and Related Health Problems (ICD-11);
* Diagnosis of aphasia, as confirmed by standardized tests (e.g., Huber et al., 1984); and
* Late subacute or consolidation phase (i.e., 0.5-6 months following stroke) where risk of post-stroke depression is particularly high (Shi et al., 2014).
Exclusion Criteria:
* Other neurological conditions;
* Pre-morbid history of depression;
* Other psychopathological conditions;
* Severely impaired vision or hearing that may prevent participants from engaging in intensive communicative-pragmatic social interaction during therapy or testing, thus adopting routine-healthcare standards from a large-scale phase-III randomized controlled trial (Breitenstein et al., 2017);
* Serious non-verbal cognitive deficits; and
* No informed consent.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04318951
Study Brief:
Protocol Section:
NCT04318951