Compare the Accuracy of MindTension Blink Eye Reflex Measuring Device to DANTAC Keypoint Electromyography (EMG) System.
NCT ID: NCT06707415
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2024-09-04
2024-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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EMG evaluated group
Participants are evaluated in both the MT1 and the Natus Dantec Keypoint systems
Auditory evoked potentials
Auditory evoked potentials in parallel systems
Interventions
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Auditory evoked potentials
Auditory evoked potentials in parallel systems
Eligibility Criteria
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Inclusion Criteria
* Healthy subjects, with no known chronic disease.
* Both genders, age between 18-45.
Exclusion Criteria
* Hearing loss.
* Pregnancy.
* Substance abuse during the last 3 months.
* Lack of cooperation.
18 Years
45 Years
ALL
Yes
Sponsors
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Carmel Medical Center
OTHER
MindTension
INDUSTRY
Responsible Party
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Principal Investigators
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Hadas Shatz Azoulay, PhD
Role: STUDY_DIRECTOR
MindTension
Locations
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Carmel Medical Center
Haifa, , Israel
Countries
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Other Identifiers
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MND-03
Identifier Type: -
Identifier Source: org_study_id