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Self Abrading Rapidly Applied Electrode Validation

Self Abrading Rapidly Applied (SARA) Electrode Phase II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02200523
Acronym
SARA
Enrollment
40
Registered
2014-07-25
Start date
2014-06-30
Completion date
2015-12-31
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

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

DEVICESARA electrode
DEVICEGold cup

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Cleveland Medical Devices Inc
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* adult and teenage

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Signal Quality Comparison Between SARA Electrode and Gold Cup Electrodeup to 1 hourThe 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

ArmCount
SARA Electrode
new electrode SARA electrode
20
Gold Cup
gold standard Gold cup
20
Total40

Baseline characteristics

CharacteristicSARA ElectrodeGold CupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants20 Participants40 Participants
Age, Continuous— years
Region of Enrollment
United States
20 participants20 participants40 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 20
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
SARA ElectrodeSignal Quality Comparison Between SARA Electrode and Gold Cup Electrode30 secondsStandard Deviation 10
Gold CupSignal Quality Comparison Between SARA Electrode and Gold Cup Electrode45 secondsStandard Deviation 10

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026