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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD055677 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal subjects | Active Comparator | Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions. |
|
| stroke subjects | Active Comparator | Stroke 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | 200 mg once daily with morning meal for three days administered only to stroke patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PVT Fastest 10 Percent of Reaction Times | This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only). | baseline and after three days of intervention |
| Power Function Exponent for Oral Bolus Estimation |
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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)
Or Behavioral evidence of stroke including:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark S Mennemeier, PhD | University of Arkansas | Principal Investigator |
| Gary McCullough, PhD | University of Central Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Conway Regional Rehabilitation Hospital | Conway | Arkansas | 72035 | United States | ||
| University of Arkansas for Medical Sciences |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Subjects Baseline | Normal subjects are persons without stroke who receive baseline, Cold Pressor Stimulation (CPS), Post CPS and Follow up interventions. Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. Post CPS: 20 minutes following the CPS condition. |
| FG001 | Stroke Subjects: Placebo Then Modafinil | Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients 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 Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. Post CPS: 20 minutes following the CPS condition. |
| FG002 | Stroke Subjects: Modafinil Then Placebo | Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients 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 Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. Post CPS: 20 minutes following the CPS condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Subjects | Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions. Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. Post CPS: 20 minutes following the CPS condition. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | percentage of change in amplitude | baseline and after three days of intervention |
|
2 years
Adverse Events were recorded in a cumulative fashion for stroke participants, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Subjects | Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions. Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. Post CPS: 20 minutes following the CPS condition. Follow up: Follow up testing occurred at 3 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stroke | Vascular disorders | Non-systematic Assessment | One participant had an additional stroke that was unrelated to the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vasovagal response | Vascular disorders | Non-systematic Assessment | One normal subject had a vasovagal response during the swallowing evaluation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Mennemeier, PhD | University of Arkansas for Medical Sciences | 501 526 7773 | msmennemeier@uams.edu |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| D005741 | Noble Gases |
| C074807 | BaseLine dental cement |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | 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 |
|
|
| Baseline | Behavioral | Observations made at baseline before any intervention |
|
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| CPS | Behavioral | Submerging each participant's foot into ice water (36-44 F) for 50 seconds. |
|
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| Post CPS | Behavioral | 20 minutes following the CPS condition. |
|
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| Follow up | Behavioral | Follow up testing occurred at 3 months |
|
|
This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only). |
| baseline and after three days of intervention |
| Time to Swallow Puree Food | This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only). | baseline and after three days of intervention |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Stroke Subjects |
Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline, CPS, and Post CPS and then are randomized to modafinil or placebo. Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. Post CPS: 20 minutes following the CPS condition. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Stroke 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. Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. |
| OG002 | Stroke Subjects: Modafinil | Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients |
| OG003 | Stroke Subjects: Placebo | 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 |
| OG004 | Stroke Subjects Placebo vs Modafinil | 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 Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients |
|
|
| Secondary | PVT Fastest 10 Percent of Reaction Times | This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only). | Posted | Mean | Standard Deviation | milliseconds | baseline and after three days of intervention |
|
|
|
| Secondary | Power Function Exponent for Oral Bolus Estimation | This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only). | Posted | Mean | Standard Deviation | exponent | baseline and after three days of intervention |
|
|
|
| Secondary | Time to Swallow Puree Food | This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only). | Posted | Mean | Standard Deviation | seconds | baseline and after three days of intervention |
|
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|
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | Stroke Subjects | Stroke 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. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients 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 Baseline: Observations made at baseline before any intervention CPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds. Post CPS: 20 minutes following the CPS condition. Follow up: Follow up testing occurred at 3 months | 2 | 7 | 6 | 7 |
|
| broken hip | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | one participant broke a hip but this was not related to the study |
|
|
| headache | Nervous system disorders | Non-systematic Assessment | headache with or without dizzyness |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | rash with or without itchyness |
|
| difficulty sleeping | Nervous system disorders | Non-systematic Assessment | report of difficulty sleeping |
|
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| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |