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Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

NCT01085903 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-10-18

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Mark S Mennemeier, PhD · University of Arkansas

  • Gary McCullough, PhD · University of Central Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01085903 on ClinicalTrials.gov