Compare the Accuracy of MindTension Blink Eye Reflex Measuring Device to DANTAC Keypoint Electromyography (EMG) System.

Not Applicable

Completed

• Conditions: Electromyography; Auditory Event-related Potential (AERP)

• Registration Number: NCT06707415
• Lead Sponsor: MindTension

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.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-09-04
• Primary Completion: 2024-09-15
• Study Completion: 2024-09-15
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-11-23
• Last Update Submitted: 2024-11-23
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Average eye blink sum	Day 1	Average eye blink sum (in millivolts) following auditory stimuli.

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel