Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

Completed · Phase 2 · Has a placebo group

Conditions studied: Spatial Neglect, Dysphagia

In brief

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.

Key facts

Study ID

NCT01085903

Run by

University of Arkansas

People needed

28

Starts

2010-03-01

Expected to finish

2015-08-01

Last updated by the study team

2016-10-18

Who can join

Age: 19 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Conway Regional Rehabilitation Hospital — Conway, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.