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

MindTension

Status: Completed

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

Treatments: Diagnostic Test: Auditory evoked potentials

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06707415

MND-03

Details and patient eligibility

About

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).

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

EMG evaluated group

Experimental group

Description:

Participants are evaluated in both the MT1 and the Natus Dantec Keypoint systems

Treatment:

Diagnostic Test: Auditory evoked potentials