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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT07039305
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80
* A diagnosis of stroke at least 6 months prior
* Residual paresis in the lower extremity (Fugl-Meyer lower extremity \[LE\] motor score \<34)
* Ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-1.0 m/s
* Ability to follow instructions, complete cognitive testing and to communicate exertion, pain and distress
* No antidepressant medications or no change in doses of psychotropic medication for at least 4 weeks prior to the study (6 weeks if newly initiated medication)
* HDRS17 question #3 and PHQ-9 question #9 regarding suicide ≤ 2
* Provision of informed consent.
In addition, depressed subjects will screen for probable major depressive disorder (Patient Health Questionnaire-9 ≥ 10) and be diagnosed using the Structured Clinical Interview for Depression (SCID) according to the DSM-5.
Exclusion Criteria:
* Unable to ambulate at least 150 feet or experienced intermittent claudication while walking
* Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's
* Dementia
* Life expectancy \<1 yr
* History of DVT or pulmonary embolism within 6 months
* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
* Severe hypertension with systolic \>200 mmHg and diastolic \>110 mmHg at rest
* Attempt of suicide in the last 2 years or suicidal risk assessed by depression screening
* Current enrollment in a rehabilitation trial to enhance motor, cognitive and or psychosocial recovery
* Severe cognitive impairment (MoCA score ≤15)
* Moderate to severe neglect that precludes cognitive testing
For brain stimulation procedures only:
* Electronic or metallic implants
* History of seizures
* Women of child bearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07039305
Study Brief:
Protocol Section:
NCT07039305