Self Abrading Rapidly Applied Electrode Validation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Self Abrading Rapidly Applied (SARA) Electrode Phase II

Conditions
-----------------
ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Intervention / Treatment
-----------------
* Device: SARA electrode
* Device: Gold cup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult and teenage Exclusion Criteria: young children damaged scalp skin sensitive or allergic to electrode paste

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SARA electrode<br>new electrode | Device: SARA electrode<br> <br> |
| Active Comparator: Gold cup<br>gold standard | Device: Gold cup<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode | The time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared. | up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, electrode