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:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT04644718
Eligibility Criteria:
Inclusion Criteria:
* Adult (18-70 years old) native Arabic speakers with first-ever symptoms of aphasia due to cortical or subcortical stroke in the left hemisphere in individuals who have had these symptoms for six months and more post-onset.
* The included participants with aphasia should demonstrate 50% or greater on the auditory verbal comprehension section of the GACAT with a cut score of 54 of total comprehension of spoken language in GACAT.
* Moderate to severe individuals with aphasia will be included in the study. These included individuals will include individuals with non-fluent aphasia only for sake of homogeneous study population. The nature (fluent versus no fluent) and severity (mild-moderate-Severe) of aphasia will be determined primarily by GACAT, and secondary by clinical history and patients' interview.
* The GACAT T-scores in naming total are used to determine aphasia severity as follows: mild aphasia ≥ 72, moderate aphasia 71-66, and severe aphasia ≤ 65.
* Recruitment of participants will include both sexes.
Exclusion Criteria:
* The exclusion criteria include any individual with hearing or vision impairments that may preclude participation of speech language therapy tasks, individuals with multiple strokes, individuals with fluent aphasia, individuals with severe apraxia of speech that is determined by a cut- score of ≤ 20 on total of repletion part in GACAT, individuals with severe non-verbal cognitive deficits as determined by a cut- off score of ≤ 50 on the cognitive total screen section in GACAT.
* The individuals who found to have any of the contraindications for tDCS.
* These contraindications include but not restricted to (cardiac pacemaker, history of seizures, implanted metal inside the head) (Pulvermüller and Fadiga, 2010).
* Furthermore; individuals with confirmed severe neurological diseases such as: epilepsy, brain tumor, and subdural hematoma are excluded from the study.
* Finally, individuals with psychiatric conditions that may include diagnosis of severe alcohol or substance, or any individual who have demonstrated recent changes (within 2 weeks prior to study inclusion) in centrally real drugs (Pulvermüller and Fadiga, 2010).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04644718
Study Brief:
Protocol Section:
NCT04644718