ClinicalTrials.gov
ClinicalTrials.gov Menu

Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02503878
Recruitment Status : Terminated (There was to much artifact on the readings and could not be interpreted)
First Posted : July 21, 2015
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
William Hand, Medical University of South Carolina

Brief Summary:
Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to monitor levels of "sedation" based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing

Condition or disease Intervention/treatment
Seizure Device: Masimo Sedline brain function monitors

Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test)
Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures


Intervention Details:
  • Device: Masimo Sedline brain function monitors
    Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to monitor levels of "sedation" based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing


Primary Outcome Measures :
  1. Masimo Sedline brain function monitor- based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be 10 adult patients over 18 years old scheduled for Wada Testing at MUSC. One of the study team members will inform patients scheduled to undergo surgery about the opportunity to participate in the study prior to surgery. Patients will review and sign a written informed consent with a research study team member.
Criteria

Inclusion Criteria:

18 years of age or older

scheduled for Wada testing at MUSC

Exclusion Criteria:

No exclusions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503878


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina

Responsible Party: William Hand, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02503878     History of Changes
Other Study ID Numbers: Pro00037965
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms