ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)
Conditions
Keywords
EEG, electrode
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* adult and teenage
Exclusion criteria
* young children * damaged scalp skin * sensitive or allergic to electrode paste
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SARA Electrode new electrode
SARA electrode | 20 |
| Gold Cup gold standard
Gold cup | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | SARA Electrode | Gold Cup | Total | — |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants | — |
| Age, Continuous | — | — | — | — years |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants | — |
| Sex: Female, Male Female | — | — | 0 Participants | — |
| Sex: Female, Male Male | — | — | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: up to 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SARA Electrode | Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode | 30 seconds | Standard Deviation 10 |
| Gold Cup | Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode | 45 seconds | Standard Deviation 10 |