Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine how stroke can alter arousal, alertness, neglect and dysphagia, and whether a medication, modafinil, can improve arousal.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Armodafinil; Modafinil; Vasoconstrictor Agents

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