NCT01085903

Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spatial Neglect
• Dysphagia

Interventions

Type	Name	Description
DRUG	Modafinil	200 mg once daily with morning meal for three days administered only to stroke patients
DRUG	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
BEHAVIORAL	Baseline	Observations made at baseline before any intervention
BEHAVIORAL	CPS	Submerging each participant's foot into ice water (36-44 F) for 50 seconds.
BEHAVIORAL	Post CPS	20 minutes following the CPS condition.
BEHAVIORAL	Follow up	Follow up testing occurred at 3 months

Timeline

• Start date: 2010-03-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2010-03-12
• Last updated: 2016-10-18
• Results posted: 2016-10-18

Locations

2 sites across 1 country: United States