Self Abrading Rapidly Applied Electrode Validation (SARA)

Cleveland Medical Devices

Status: Completed

Conditions: ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Treatments: Device: Gold cup; Device: SARA electrode

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02200523

ns053116_SARA_electrode

R44NS053116 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adult and teenage

Exclusion criteria

• young children
• damaged scalp skin
• sensitive or allergic to electrode paste

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

SARA electrode

Experimental group

Description:

new electrode

Treatment:

Device: SARA electrode

Gold cup

Active Comparator group

Description:

gold standard

Treatment:

Device: Gold cup