A clinical study aimed to compare the accuracy and precision of the MindTension MT1 auditory evoked response parallel to an FDA cleared device (Natus DANTEC Keypoint).
Mindtension device measures the orbicularis muscle response to auditory stimuli, the device is backed up by an algorithm that calculates several parameters of startle reflex and startle related indices. In the present study we aim to test the validity, accuracy and precision of MT1 system compared to an FDA cleared device, the Natus DANTEC Keypoint EMG system (K944547). The aim of this clinical trial is to demonstrate the accuracy and precision of the MT1 device to the FDA cleared Natus DANTEC Keypoint EMG system that is used in the EMG unit. Participants (n=38) will be evaluated for eligibility of inclusion. As this is paired-group design study, patients will be randomized in a 1:1 ratio to group 1 (Right facial side with MT1 device), or group 2 (Right facial side Natus keypoint device), each patient will be tested using both devices at the same time. The test is 6 minutes in duration. The results will be compared within and between subject analysis. Safety will be assessed through collection and analysis of adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
38
Auditory evoked potentials in parallel systems
Carmel Medical Center
Haifa, Israel
Average maximal peak levels
The average peak levels (in millivolts) following auditory stimulus.
Time frame: Day 1
Average peak index
The average index (in milliseconds) following auditory stimulus.
Time frame: Day 1
Average eye blink width
Average eye blink width (in milliseconds) following auditory stimuli.
Time frame: Day 1
Average inhibition
Average inhibition (in percent) following paired auditory stimuli.
Time frame: Day 1
Average eye blink sum
Average eye blink sum (in millivolts) following auditory stimuli.
Time frame: Day 1
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