Trial Outcomes & Findings for Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia (NCT NCT01085903)
NCT ID: NCT01085903
Last Updated: 2016-10-18
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
baseline and after three days of intervention
Results posted on
2016-10-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
4
|
3
|
|
Overall Study
COMPLETED
|
21
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
Baseline characteristics by cohort
| Measure |
Normal Subjects
n=21 Participants
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.
|
Stroke Subjects
n=7 Participants
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
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.286 years
STANDARD_DEVIATION 21.462 • n=5 Participants
|
71.429 years
STANDARD_DEVIATION 9.914 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and after three days of interventionThis 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).
Outcome measures
| Measure |
Normal Subjects: Baseline vs CPS
n=21 Participants
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.
|
Stroke Subjects: Baseline vs CPS
n=7 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.
|
Stroke Subjects: Modafinil
n=7 Participants
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
|
Stroke Subjects: Placebo
n=7 Participants
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
|
Stroke Subjects Placebo vs Modafinil
n=7 Participants
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
|
|---|---|---|---|---|---|
|
P50 Percent Habituation Score
|
-44.12 percentage of change in amplitude
Standard Deviation 59.29
|
-45.84 percentage of change in amplitude
Standard Deviation 228.09
|
113.63 percentage of change in amplitude
Standard Deviation 154.5
|
61.41 percentage of change in amplitude
Standard Deviation 102.5
|
52.223 percentage of change in amplitude
Standard Deviation 222.94
|
SECONDARY outcome
Timeframe: baseline and after three days of interventionThis 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).
Outcome measures
| Measure |
Normal Subjects: Baseline vs CPS
n=21 Participants
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.
|
Stroke Subjects: Baseline vs CPS
n=7 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.
|
Stroke Subjects: Modafinil
n=7 Participants
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
|
Stroke Subjects: Placebo
n=7 Participants
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
|
Stroke Subjects Placebo vs Modafinil
n=7 Participants
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
|
|---|---|---|---|---|---|
|
PVT Fastest 10 Percent of Reaction Times
|
-10.57 milliseconds
Standard Deviation 21.66
|
20.57 milliseconds
Standard Deviation 29.20
|
244.71 milliseconds
Standard Deviation 186.62
|
235.64 milliseconds
Standard Deviation 150.62
|
9.07 milliseconds
Standard Deviation 38.73
|
SECONDARY outcome
Timeframe: baseline and after three days of interventionThis 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).
Outcome measures
| Measure |
Normal Subjects: Baseline vs CPS
n=21 Participants
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.
|
Stroke Subjects: Baseline vs CPS
n=7 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.
|
Stroke Subjects: Modafinil
n=7 Participants
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
|
Stroke Subjects: Placebo
n=7 Participants
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
|
Stroke Subjects Placebo vs Modafinil
n=7 Participants
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
|
|---|---|---|---|---|---|
|
Power Function Exponent for Oral Bolus Estimation
|
.014 exponent
Standard Deviation .113
|
-.004 exponent
Standard Deviation .196
|
.54 exponent
Standard Deviation .17
|
.49 exponent
Standard Deviation .19
|
.04 exponent
Standard Deviation .08
|
SECONDARY outcome
Timeframe: baseline and after three days of interventionThis 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).
Outcome measures
| Measure |
Normal Subjects: Baseline vs CPS
n=21 Participants
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.
|
Stroke Subjects: Baseline vs CPS
n=7 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.
|
Stroke Subjects: Modafinil
n=7 Participants
Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
|
Stroke Subjects: Placebo
n=7 Participants
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
|
Stroke Subjects Placebo vs Modafinil
n=7 Participants
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
|
|---|---|---|---|---|---|
|
Time to Swallow Puree Food
|
.029 seconds
Standard Deviation .121
|
-.058 seconds
Standard Deviation .512
|
.48 seconds
Standard Deviation 1.05
|
.12 seconds
Standard Deviation .11
|
.36 seconds
Standard Deviation 1.06
|
Adverse Events
Normal Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Stroke Subjects
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal Subjects
n=21 participants at risk
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
|
Stroke Subjects
n=7 participants at risk
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
|
|---|---|---|
|
Vascular disorders
stroke
|
0.00%
0/21 • 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.
|
14.3%
1/7 • 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.
|
|
Musculoskeletal and connective tissue disorders
broken hip
|
0.00%
0/21 • 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.
|
14.3%
1/7 • 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.
|
Other adverse events
| Measure |
Normal Subjects
n=21 participants at risk
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
|
Stroke Subjects
n=7 participants at risk
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
|
|---|---|---|
|
Vascular disorders
vasovagal response
|
4.8%
1/21 • Number of events 1 • 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.
|
0.00%
0/7 • 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.
|
|
Nervous system disorders
headache
|
0.00%
0/21 • 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.
|
28.6%
2/7 • Number of events 2 • 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.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/21 • 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.
|
42.9%
3/7 • Number of events 3 • 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.
|
|
Nervous system disorders
difficulty sleeping
|
0.00%
0/21 • 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.
|
14.3%
1/7 • Number of events 1 • 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.
|
Additional Information
Mark Mennemeier, PhD
University of Arkansas for Medical Sciences
Phone: 501 526 7773
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place