MetroHealth Research Institute
Cleveland, Ohio, 44109, United States
Completed
NCT Number: NCT02200523
Self Abrading Rapidly Applied Electrode Validation
The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. The investigators believe that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required for the EEG recording will make EEG more feasible in time critical situations and will improve patient care and service. The clinical testing in Phase II will investigate patient acceptance, clinician acceptance, time savings, and signal quality for 3 different environments: the large hospital institution, a small rural hospital setting and in an emergency department.
Completed
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Notify MeKey information
Age range
12 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. This proposed single-use electrode will consist of a Snap Top, Ag/AgCl Snap Conductor, Conductive Adhesive, and Abrader Tines in a custom molded housing and packed on a backing sheet. After removing the backing, the technician simply parts the hair with one hand and with the other hand rubs the electrode back and forth and then presses the electrode into position on the scalp. The proposed system combines the cumbersome and time-consuming skin preparation, electrode preparation and electrode fixation into one easy step. The investigators believe that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required for the EEG recording will make EEG more feasible in time critical situations and will improve patient care and service.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- adult and teenage
Exclusion criteria
- young children
- damaged scalp skin
- sensitive or allergic to electrode paste
Treatment and study plan
SARA electrode
DeviceGold cup
DevicePrimary outcomes
-
Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode
Time frame: up to 1 hour
The time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared.
Sponsors and collaborators
Lead sponsor
Cleveland Medical Devices Inc
Industry
Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
Registry information
Official study title
Self Abrading Rapidly Applied (SARA) Electrode Phase II
Acronym: SARA
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jul 25, 2014
- Registry last updated
- Aug 13, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.