Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
2 other identifiers
interventional
28
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2010
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 9, 2010
CompletedFirst Posted
Study publicly available on registry
March 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
October 18, 2016
CompletedOctober 18, 2016
October 1, 2016
5.4 years
March 9, 2010
July 25, 2016
October 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
P50 Percent Habituation Score
This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).
baseline and after three days of intervention
Secondary Outcomes (3)
PVT Fastest 10 Percent of Reaction Times
baseline and after three days of intervention
Power Function Exponent for Oral Bolus Estimation
baseline and after three days of intervention
Time to Swallow Puree Food
baseline and after three days of intervention
Study Arms (2)
normal subjects
ACTIVE COMPARATORNormal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.
stroke subjects
ACTIVE COMPARATORStroke 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.
Interventions
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
Eligibility Criteria
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
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Conway Regional Rehabilitation Hospital
Conway, Arkansas, 72035, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Mennemeier, PhD
- Organization
- University of Arkansas for Medical Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Mark S Mennemeier, PhD
University of Arkansas
- PRINCIPAL INVESTIGATOR
Gary McCullough, PhD
University of Central Arkansas
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2010
First Posted
March 12, 2010
Study Start
March 1, 2010
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 18, 2016
Results First Posted
October 18, 2016
Record last verified: 2016-10