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NCT02503878 Clinical Trial

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

Seizure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02503878
Other study ID # Pro00037965
Secondary ID
Status Terminated
Phase N/A
First received July 17, 2015
Last updated February 29, 2016
Start date December 2014
Est. completion date February 2016

Study information
Verified date February 2016
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 7
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

18 years of age or older

scheduled for Wada testing at MUSC

Exclusion Criteria:

No exclusions

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (1)
Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 1 year No
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