Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
NCT ID: NCT01085903
Last Updated: 2016-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2010-03-31
2015-08-31
Brief Summary
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Detailed Description
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A new direction of this application is to view neglect and dysphagia as different disorders that share a common deficit in magnitude estimation (ME). ME refers to one's ability to perceive the intensity of sensory stimulation. Deficits in ME explain how much of a stimulus is neglected by stroke patients. Sensory deficits are also known to produce dysphagia. Perceptual deficits influence how patients response to stimuli like failing to act on all stimuli present (neglect) and failing to generate swallowing reflexes sufficient for normal bolus flow (dysphagia).
We know from previous work that ME is altered by change in cortical arousal following stroke (decreased or hypoarousal). Hypoarousal is evidenced by objective and subjective post-stroke fatigue and daytime sleepiness which occurs in 50% of stroke patients and can persist chronically. Increasing arousal could potentially reverse the perceptual deficits associated with hypoarousal and improve neglect and dysphagia. This proposal manipulates arousal in two ways. Cold pressor stimulation (CPS), immersing the foot in cold water for 50 seconds, is used to increase arousal and reverse neglect and dysphagia temporarily. A brief, 3-day trial of modafinil (Provigil) versus placebo is then used in stroke patients to learn if a positive response to cold-pressor stimulation can predicts patients who respond positively to modafinil.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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normal subjects
Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.
Baseline
Observations made at baseline before any intervention
CPS
Submerging each participant's foot into ice water (36-44 F) for 50 seconds.
Post CPS
20 minutes following the CPS condition.
Follow up
Follow up testing occurred at 3 months
stroke subjects
Stroke 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.
Modafinil
200 mg once daily with morning meal for three days administered only to stroke patients
Placebo
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
Baseline
Observations made at baseline before any intervention
CPS
Submerging each participant's foot into ice water (36-44 F) for 50 seconds.
Post CPS
20 minutes following the CPS condition.
Follow up
Follow up testing occurred at 3 months
Interventions
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Modafinil
200 mg once daily with morning meal for three days administered only to stroke patients
Placebo
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
Baseline
Observations made at baseline before any intervention
CPS
Submerging each participant's foot into ice water (36-44 F) for 50 seconds.
Post CPS
20 minutes following the CPS condition.
Follow up
Follow up testing occurred at 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
19 Years
85 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Mark S Mennemeier, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Gary McCullough, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Central Arkansas
Locations
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Conway Regional Rehabilitation Hospital
Conway, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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110644
Identifier Type: -
Identifier Source: org_study_id
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