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Phase 2 N=28 Randomized Double-blind Treatment

Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

Spatial Neglect · Dysphagia

Enrolled (actual)
28
Serious AEs
7.1%
Results posted
Oct 2016
Primary outcome: Primary: P50 Percent Habituation Score — -44.12; -45.84; 113.63; 61.41 percentage of change in amplitude

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Modafinil (Drug); Placebo (Drug); Baseline (Behavioral); CPS (Behavioral); Post CPS (Behavioral); Follow up (Behavioral)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
University of Arkansas
Primary completion
Aug 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
P50 Percent Habituation Score
-44.12; -45.84; 113.63; 61.41; 52.223
SECONDARY
PVT Fastest 10 Percent of Reaction Times
-10.57; 20.57; 244.71; 235.64; 9.07
SECONDARY
Power Function Exponent for Oral Bolus Estimation
.014; -.004; .54; .49; .04
SECONDARY
Time to Swallow Puree Food
.029; -.058; .48; .12; .36

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01085903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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