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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT01085903
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Willingness to complete study procedures
* Ability to comprehend and sign informed consent
* Evidence of unilateral, ischemic stroke based on:
* Neuroimaging (clinically obtained imaging studies showing evidence of stroke)
* Acceptable categories of stroke include:
* Unilateral ischemic stroke
* Atherothrombotic stroke
* Cardioembolic stroke
* Lacunar stroke \>1.5 cm
* Chronic stable, unilateral hemorrhagic stroke
* Or Behavioral evidence of stroke including:
* Hemiplegia
* Unilateral sensory impairment
* Localized higher cortical dysfunction (e.g. neglect,dysphagia, apraxia)
Exclusion Criteria:
* Cardiac valvular disease
* Left heart hypertrophy
* Poorly controlled hypertension
* Active variant angina
* Pre-menopausal women capable of having children, including those using active contraception (precaution for study medication and not applicable to normal subjects)
* Severe renal or hepatic disease
* History of psychosis or substance abuse
* Patients on other Central Nervous System (CNS) stimulants, dopamine agonists or antagonists (antipsychotics)
* Severe speech comprehension deficit and/or inability to communicate responses
* Allergies that could put the research subject at risk during the course of the study
* Cannot speak English
* Active cerebral neurologic disease other than stroke such as multiple sclerosis or Alzheimer's Disease
* Active psychiatric illness except past history of treated depression or anxiety disorders
* For persons needing an MRI - standard MRI exclusion criteria (cardiac pacemaker or defibrillator, artificial heart valves, metallic aneurysm clips eye or ear implants, implanted insulin or infusion pumps, battery activated stimulators, and history of claustrophobia)
* Concomitant medications excluded: Based on recommendations of manufacturer, the following concomitant medications are excluded: Tricyclic antidepressants and Monoamine oxidase (MAO) inhibitors. Any other CNS stimulation producing medications. Antifungal agents Itraconazole or Ketoconazole as plasma concentrations of modafinil may be increased.
* Stroke patients will be excluded from the modafinil trial if they cannot swallow a capsule.
* Stroke patients are excluded if they are able to become pregnant
* Any other criteria that the PI or study physicians feel would put the volunteer's health at risk during the course of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT01085903
Study Brief:
Protocol Section:
NCT01085903