Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
Condition: Spatial Neglect; Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Neglect and dysphagia are two of the most problematic behavioral disorders encountered in
      stroke rehabilitation with 300,000 patients affected annually in the US. Both disorders
      impede progress in therapy and both lead to costly medical complications, like falls which
      are associated with neglect and aspiration pneumonia and malnutrition which are associated
      with dysphagia. No widely accepted pharmacological treatment exists for either disorder.

      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.
    

Intervention name(s): Modafinil; Placebo; Baseline; CPS; Post CPS; Follow up
Intervention type(s): Drug; Drug; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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
Other intervention name(s): Provigil; inert; baseline observation; cold pressor stimulation; post cold pressor stimulation; three month follow up
Intervention MeSH terms: Vasoconstrictor Agents; Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Spatial Neglect; Dysphagia; Arousal; Modafinil; Stroke