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| ID | Type | Description | Link |
|---|---|---|---|
| R44NS053116 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARA electrode | Experimental | new electrode |
|
| Gold cup | Active Comparator | gold standard |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARA electrode | Device |
| ||
| Gold cup |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Weimer | Great Lakes NeuroTechnologies Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Research Institute | Cleveland | Ohio | 44109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SARA Electrode | new electrode SARA electrode |
| FG001 | Gold Cup | gold standard Gold cup |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SARA Electrode | new electrode SARA electrode |
| BG001 | Gold Cup | gold standard Gold cup |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | seconds | up to 1 hour |
|
|
duration of the testing (<1 hour)
ALL Adverse Events were monitored during the test by the clinician. Due to low risk of the procedure no subject was considered to be at risk for Mortality nor Serious Adverse Events but if one should occur during the test the clinician would observe and report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SARA Electrode | new electrode SARA electrode | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Weimer | Cleveland Medical Devices | 216-791-6720 | sweimer@clevemed.com |
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|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | anonymous data did not include specific age information | Mean | Standard Deviation | years |
|
| Sex: Female, Male | anonymous data did not include gender information | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Gold Cup | gold standard Gold cup | 0 | 20 | 0 | 20 | 0 | 20 |
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