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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT01928602
Eligibility Criteria:
Inclusion Criteria:
* Left hemisphere stroke
* Clinical presentation of first ever stroke
* Nonfluent/Expressive Aphasia: impairment in language production and spared language comprehension
* Age \>18 years
* Adequate co-operation for scanning
* Right handed before stroke as tested with the Edinburgh inventory
* Native British-English speakers (this is due to the nature of the fMRI task and inner speech battery, which rely upon words that are rhymes or homophones in the British English language)
* No history of neurological or psychiatric disorders
* No current specific cognitive deficit other than the language deficit
* No contra-indication to MRI scan as indicated by the WBIC protocol
* Patients able to lie flat in the scanner for 2 hours
* Consent obtained prior to initiating the study from the patient, in accordance with Local Research Ethics Committee guidelines
* Stroke and subsequent aphasia having been present for more than 12 months (ie, chronic)
Exclusion Criteria:
For successful fMRI scans (relevant for all participants):
* Women with any chance of pregnancy
* Claustrophobia
* Any contra-indication to MRI as indicated by the WBIC protocol
* Concomitant medical disorder that means the patient is unable to lie flat comfortably in the scanner for a maximum of 2 hours (e.g. poorly controlled or severe respiratory disease or severe joint disease)
All recruited patients:
* History of significant pre-morbid cognitive impairment
* Alcohol or illicit drug abuse
* Severe deafness or visual impairment
* History of significant neurological disease (e.g. epilepsy, multiple sclerosis)
* Major organ failure that may complicate imaging studies (e.g. significant cardiac or liver disease)
Of those patients recruited, further exclusion from crossover study:
* Demonstration of intact inner speech with good overt speech
* Demonstration of poor inner speech with poor overt speech
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01928602
Study Brief:
Protocol Section:
NCT01928602