Spatial Neglect | Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
Spatial Neglect research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Modafinil200 mg once daily with morning meal for three days administered only to stroke patients
Drug:PlaceboSubjects 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
Behavioral:BaselineObservations made at baseline before any intervention
Behavioral:CPSSubmerging each participant's foot into ice water (36-44 F) for 50 seconds.
Behavioral:Post CPS20 minutes following the CPS condition.
Behavioral:Follow upFollow up testing occurred at 3 months
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
normal subjectsNormal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.
stroke subjectsStroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.
Start Date: March 2010
Completed Date: August 2015
Phase: Phase 2
Primary Outcome: P50 Percent Habituation Score
Secondary Outcome: PVT Fastest 10 Percent of Reaction Times
Study sponsors, principal investigator, and references
Principal Investigator: Mark S Mennemeier, PhD
Lead Sponsor: University of Arkansas
Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)