Trial · NCT01085903

Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

NCT01085903, Phase 2, Completed, University of Arkansas; results first posted 2016-10-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia. Trials, record NCT01085903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01085903

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
NCT number: NCT01085903
Status: Completed
Phases: Phase 2
Enrollment: 28 participants, actual
Lead sponsor: University of Arkansas
Conditions: Spatial Neglect, Dysphagia
Interventions: Modafinil, Placebo, Baseline, CPS, Post CPS, Follow up
First posted: 2010-03-12
Last updated: 2016-10-18
Results first posted: 2016-10-18

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	P50 Percent Habituation Score	baseline and after three days of intervention	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).
Secondary	PVT Fastest 10 Percent of Reaction Times	baseline and after three days of intervention	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).
Secondary	Power Function Exponent for Oral Bolus Estimation	baseline and after three days of intervention	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).
Secondary	Time to Swallow Puree Food	baseline and after three days of intervention	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).

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	P50 Percent Habituation Score	baseline and after three days of intervention	percentage of change in amplitude	MEAN
SECONDARY	PVT Fastest 10 Percent of Reaction Times	baseline and after three days of intervention	milliseconds	MEAN
SECONDARY	Power Function Exponent for Oral Bolus Estimation	baseline and after three days of intervention	exponent	MEAN
SECONDARY	Time to Swallow Puree Food	baseline and after three days of intervention	seconds	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
P50 Percent Habituation Score	Normal Subjects: Baseline vs CPS	-44.12	Standard Deviation 59.29	percentage of change in amplitude
P50 Percent Habituation Score	Stroke Subjects: Baseline vs CPS	-45.84	Standard Deviation 228.09	percentage of change in amplitude
P50 Percent Habituation Score	Stroke Subjects: Modafinil	113.63	Standard Deviation 154.5	percentage of change in amplitude
P50 Percent Habituation Score	Stroke Subjects: Placebo	61.41	Standard Deviation 102.5	percentage of change in amplitude
P50 Percent Habituation Score	Stroke Subjects Placebo vs Modafinil	52.223	Standard Deviation 222.94	percentage of change in amplitude
PVT Fastest 10 Percent of Reaction Times	Normal Subjects: Baseline vs CPS	-10.57	Standard Deviation 21.66	milliseconds
PVT Fastest 10 Percent of Reaction Times	Stroke Subjects: Baseline vs CPS	20.57	Standard Deviation 29.20	milliseconds
PVT Fastest 10 Percent of Reaction Times	Stroke Subjects: Modafinil	244.71	Standard Deviation 186.62	milliseconds
PVT Fastest 10 Percent of Reaction Times	Stroke Subjects: Placebo	235.64	Standard Deviation 150.62	milliseconds
PVT Fastest 10 Percent of Reaction Times	Stroke Subjects Placebo vs Modafinil	9.07	Standard Deviation 38.73	milliseconds

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Normal Subjects Baseline	21
Overall Study	STARTED	Stroke Subjects: Placebo Then Modafinil	4
Overall Study	STARTED	Stroke Subjects: Modafinil Then Placebo	3
Overall Study	COMPLETED	Normal Subjects Baseline	21
Overall Study	COMPLETED	Stroke Subjects: Placebo Then Modafinil	4
Overall Study	COMPLETED	Stroke Subjects: Modafinil Then Placebo	3
Overall Study	NOT COMPLETED	Normal Subjects Baseline	0
Overall Study	NOT COMPLETED	Stroke Subjects: Placebo Then Modafinil	0
Overall Study	NOT COMPLETED	Stroke Subjects: Modafinil Then Placebo	0

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	vasovagal response	Vascular disorders	Normal Subjects	1	21	1
other	vasovagal response	Vascular disorders	Stroke Subjects	0	7	0
other	headache	Nervous system disorders	Normal Subjects	0	21	0
other	headache	Nervous system disorders	Stroke Subjects	2	7	2
other	rash	Skin and subcutaneous tissue disorders	Normal Subjects	0	21	0
other	rash	Skin and subcutaneous tissue disorders	Stroke Subjects	3	7	3
other	difficulty sleeping	Nervous system disorders	Normal Subjects	0	21	0
other	difficulty sleeping	Nervous system disorders	Stroke Subjects	1	7	1
serious	stroke	Vascular disorders	Normal Subjects	0	21
serious	stroke	Vascular disorders	Stroke Subjects	1	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Normal Subjects
Total, all-cause mortality	Stroke Subjects
Total, other adverse events	Normal Subjects	1	21
Total, other adverse events	Stroke Subjects	6	7
Total, serious adverse events	Normal Subjects	0	21
Total, serious adverse events	Stroke Subjects	2	7

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21HD055677	Identifying and Treating Arousal-Related Deficits in Neglect and Dysphagia	MENNEMEIER, MARK S	UNIV OF ARKANSAS FOR MED SCIS	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2009 to 2010

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Normal Subjects vs Stroke Subjects: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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