Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia


Phase 2 Results

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