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A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements.
A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and reliability for assessment and monitoring of TEP's as neurophysiological measurements.
Safety:
Upper limit of the 95% CI of the device related serious adverse event (SAE) rate is less than or equal to 3.6%
Performance:
Demonstrate differentiation of relevant clinical groups
Reliability:
An acceptable mean Interclass correlation (ICC) statistic (six stimulation) is at least 0.6 Additionally, the within subject variability should be lower than the between subject variability.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is a retrospective analysis study of data collected with a diagnostic medical device | Other | Transcranial Magnetic stimulation and Electroencephalogram |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical Excitability | Amplitude of the TMS Evoked Response (TEP)- Mean amplitude deviation of the entire TEP time frame | baseline |
| Specific Peak Amplitudes | N45,P60,N100,P180- Amplitudes at corresponding latencies | baseline |
| GMFP | Global Mean Field Potential- It is a measure of the standard deviation of the potentials across all electrodes, reflecting the overall activity of the brain | baseline |
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Normal Population:
Inclusion Criteria:
Exclusion Criteria:
Clinical groups:
Inclusion criteria:
Exclusion criteria:
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Male and Female subjects at the ages of 50-75
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QuantalX Neuroscience Ltd. | Kfar Saba | Center | 4453001 | Israel |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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