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Completed

NCT Number: NCT06707415

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

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).

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmel Medical Center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auditory evoked potentials

Diagnostic Test

Auditory evoked potentials in parallel systems

Primary outcomes

  1. Average maximal peak levels

    Time frame: Day 1

    The average peak levels (in millivolts) following auditory stimulus.

  2. Average peak index

    Time frame: Day 1

    The average index (in milliseconds) following auditory stimulus.

  3. Average eye blink width

    Time frame: Day 1

    Average eye blink width (in milliseconds) following auditory stimuli.

  4. Average inhibition

    Time frame: Day 1

    Average inhibition (in percent) following paired auditory stimuli.

Secondary outcomes

  1. Average eye blink sum

    Time frame: Day 1

    Average eye blink sum (in millivolts) following auditory stimuli.

Sponsors and collaborators

Lead sponsor

MindTension

Industry

Collaborators

  • Carmel Medical Center

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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