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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT05194566
Eligibility Criteria:
Individuals with aphasia (assessed using the Boston Diagnostic Aphasia Examination) who perform the Naming Task in the range of 10%-60% accuracy will be included in the study. The overall baseline score in the Naming Task will be estimated from the two baseline measurements.
Inclusion Criteria:
* diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist).
* presence of a focus of injury in the left hemisphere (within one hemisphere only) as a result of the first ischemic or hemorrhagic stroke (based on CT/MRI examination);
* chronic stage of the disease - time since the stroke occurred over 6 months.
* ability to achieve an accuracy in the Naming Task of 10-60%.
* 18-80 years
* right-handedness before the stroke.
* ability to give informed written consent.
* fluency in English.
Exclusion Criteria:
* severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command.
* presence of metal implants in the skull.
* presence of major untreated or unstable psychiatric disease.
* history of epilepsy or seizures.
* ongoing medication that increases the risk of epileptic seizures.
* presence in the body of cardiac stimulators or pacemaker.
* history of speech, language, hearing, or intellectual disability during childhood.
* pregnancy (based on declarations)
Exclusion criteria during the trial:
* high intolerance to stimulation.
* occurrence of an epileptic seizure.
* other previously absent neurological or mental symptoms
Withdrawal criteria:
* high intolerance to stimulation (participants experience severe discomfort during stimulation);
* occurrence of an epileptic seizure;
* other previously absent neurological, physical or mental symptoms.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05194566
Study Brief:
Protocol Section:
NCT05194566