SeizureNCT02503878
Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test
An observational study of Seizure, run by Medical University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seizure
- What is being tested?
- Masimo Sedline brain function monitors
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 18 years of age or older
- scheduled for Wada testing at MUSC
Who cannot join
- No exclusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test)
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
- Conditions
- Seizure
- Being tested
- Masimo Sedline brain function monitors
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: There was to much artifact on the readings and could not be interpreted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizureStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Hand, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503878
- Sponsor's protocol ID
- Pro00037965
- Status last verified
- Feb 2016
- First submitted
- 17 Jul 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test)
- ClinicalTrials.gov ID
- NCT02503878
- Acronym / sponsor ID
- Pro00037965
- Conditions
- Seizure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: There was to much artifact on the readings and could not be interpreted
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18 years of age or older
- scheduled for Wada testing at MUSC
Key exclusion criteria (1 listed)
- No exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo Sedline brain function monitorsMasimo 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 | Device | – |
Primary outcome
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
Results and safety
The study was stopped early (reason given: There was to much artifact on the readings and could not be interpreted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizure, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: There was to much artifact on the readings and could not be interpreted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.