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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT07113067
Eligibility Criteria:
Inclusion Criteria:
* 40 years old or greater
* Right- or left-hemisphere ischemic or hemorrhagic stroke with at least 6 months chronicity
* Symptomatic apathy as confirmed by (A) total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥39
* Ability to participate in psychometric testing and cognitive tasks
* Intact cortex at the TMS target site as confirmed by pre-treatment MRI
* Ability to have a co-participant/caregiver who meets the criteria as detailed below.
Exclusion Criteria:
* Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage
* Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia)
* Moderate or severe global aphasia
* Visual impairment precluding completion of cognitive tasks
* Presence of contraindications to MRI or TMS including electrically, magnetically or mechanically activated metal or nonmetal implants such as cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system;
* Pregnancy (to be later confirmed by UPT in any premenopausal female participants)
* History of a seizure disorder
* Preexisting scalp lesion, wound, bone defect, or hemicraniectomy
* Claustrophobia precluding ability to undergo an MRI
* Active substance use disorder
* Psychotic disorders
* Bipolar 1 Disorder
* Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)30 or suicide attempt in the previous year
For CO-PARTICIPANT/CAREGIVER:
Inclusion Criteria:
* Age 18 years or older
* Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's cognitive and everyday functioning.
Exclusion Criteria:
\- Unable to engage with study procedures in which Co-Participant input is needed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT07113067
Study Brief:
Protocol Section:
NCT07113067