Electromyography, Auditory Event-related Potential (AERP)
Conditions
Keywords
MT1, Electromyography, Auditory evoked potentials
Brief summary
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).
Detailed description
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.
Interventions
DIAGNOSTIC_TESTAuditory evoked potentials
Auditory evoked potentials in parallel systems
Sponsors
Carmel Medical Center
MindTension
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject's informed consent. * Healthy subjects, with no known chronic disease. * Both genders, age between 18-45.
Exclusion criteria
* Any current co-morbid Chronic illness. * Hearing loss. * Pregnancy. * Substance abuse during the last 3 months. * Lack of cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average maximal peak levels | Day 1 | The average peak levels (in millivolts) following auditory stimulus. |
| Average peak index | Day 1 | The average index (in milliseconds) following auditory stimulus. |
| Average eye blink width | Day 1 | Average eye blink width (in milliseconds) following auditory stimuli. |
| Average inhibition | Day 1 | Average inhibition (in percent) following paired auditory stimuli. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average eye blink sum | Day 1 | Average eye blink sum (in millivolts) following auditory stimuli. |
Countries
Israel
Outcome results
None listed