Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
Condition: Spatial Neglect; Dysphagia
MeSH terms: Deglutition Disorders
Intervention: Modafinil; Placebo; Baseline; CPS; Post CPS; Follow up
Intervention description: 200 mg once daily with morning meal for three days administered only to stroke patients; Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients; Observations made at baseline before any intervention; Submerging each participant's foot into ice water (36-44 F) for 50 seconds.; 20 minutes following the CPS condition.; Follow up testing occurred at 3 months
Intervention MeSH terms: Vasoconstrictor Agents; Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 19 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Spatial Neglect; Dysphagia; Arousal; Modafinil; Stroke

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.
    

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