NCT02503878

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

July 17, 2015

Last Update Submit

February 29, 2016

Conditions

Seizure

Outcome Measures

Primary Outcomes (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

    1 year

Interventions

Masimo Sedline brain function monitorsDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • years of age or older
  • scheduled for Wada testing at MUSC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 21, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 2, 2016

Record last verified: 2016-02

Locations

US(1)