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Self Abrading Rapidly Applied Electrode Validation (SARA)

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ClinicalTrials.gov Identifier: NCT02200523
Recruitment Status : Completed
First Posted : July 25, 2014
Results First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder) Device: SARA electrode Device: Gold cup Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Self Abrading Rapidly Applied (SARA) Electrode Phase II
Study Start Date : June 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: SARA electrode
new electrode
Device: SARA electrode
Active Comparator: Gold cup
gold standard
Device: Gold cup



Primary Outcome Measures :
  1. Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult and teenage

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200523


Locations
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United States, Ohio
MetroHealth Research Institute
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Cleveland Medical Devices Inc
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Sarah Weimer Great Lakes NeuroTechnologies Inc.
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Responsible Party: Cleveland Medical Devices Inc
ClinicalTrials.gov Identifier: NCT02200523    
Other Study ID Numbers: ns053116_SARA_electrode
R44NS053116 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2014    Key Record Dates
Results First Posted: August 13, 2020
Last Update Posted: August 13, 2020
Last Verified: August 2020
Keywords provided by Cleveland Medical Devices Inc:
EEG
electrode