Self Abrading Rapidly Applied Electrode Validation

Not Applicable

Completed

• Conditions: ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)
• Interventions: Device: SARA electrode; Device: Gold cup

• Registration Number: NCT02200523
• Lead Sponsor: Cleveland Medical Devices Inc

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.

Study Timeline

• Study First Submitted: 2014-02-05
• Study Start: 2014-06
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-25
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Results First Submitted: 2019-07-22
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-13
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• adult and teenage

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SARA electrode	SARA electrode	new electrode
Gold cup	Gold cup	gold standard

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

MetroHealth Research Institute; 🇺🇸 Cleveland, Ohio, United States