NCT06707415

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

A Clinical Study to Compare the Accuracy and Precision of the MindTension Blink Eye Reflex Measuring (Evoked Response)Device to DANTAC Keypoint EMG System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: MindTension · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Electromyography
• Auditory Event-related Potential (AERP)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Auditory evoked potentials	Auditory evoked potentials in parallel systems

Timeline

• Start date: 2024-09-04
• Primary completion: 2024-09-15
• Completion: 2024-09-15
• First posted: 2024-11-27
• Last updated: 2024-11-27

Locations

1 site across 1 country: Israel