Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia|
- Predicting response to modafinil among subjects with neglect [ Time Frame: 1 month ] [ Designated as safety issue: No ]We will measure electrophysiological and behavioral indicators of arousal, magnitude estimation in stroke stubjects with and without neglect behavior and in normal control subjects at baseline, immediately following and 20 minutes after cold pressor stimulation. We will then determine in stroke subjects if a response to cold pressor stimulation predicts a response to modafinil (Provigil) and whether either manipulation predicts longer-term improvement (100+/-10 days).
- Predicting response to modafinil among subjects with dysphagia [ Time Frame: 1 month ] [ Designated as safety issue: No ]We will measure arousal, magnitude estimation for pharyngeal stimulation and swallowing before and after cold pressor stimulation in groups of stroke subjects with and without dysphagia and neglect and in normal control subjects. We will then determine in stroke subjects if a response to cold pressor stimulation predicts a response to modafinil (Provigil) and whether either manipualtion predicts longer-term improvement (100 +/-10 days).
|Study Start Date:||March 2010|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Active Comparator: modafinil
Stroke subjects will receive a brief 3-day trial of modafinil and repeat experimental measures.
200 mg once daily with morning meal for three days
Placebo Comparator: placebo
Stroke subjects will receive a brief 3-day trial of placebo and repeat experimental measures.
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.
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, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085903
|United States, Arkansas|
|Conway Regional Rehabilitation Hospital|
|Conway, Arkansas, United States, 72035|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Mark S Mennemeier, PhD||University of Arkansas|
|Principal Investigator:||Gary McCullough, PhD||University of Central Arkansas|