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

November 23, 2024 updated by: MindTension

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Carmel Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMG evaluated group
Participants are evaluated in both the MT1 and the Natus Dantec Keypoint systems
Diagnostic test: Auditory evoked potentials
Auditory evoked potentials in parallel systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average maximal peak levels
Time Frame: Day 1
The average peak levels (in millivolts) following auditory stimulus.
Day 1
Average peak index
Time Frame: Day 1
The average index (in milliseconds) following auditory stimulus.
Day 1
Average eye blink width
Time Frame: Day 1
Average eye blink width (in milliseconds) following auditory stimuli.
Day 1
Average inhibition
Time Frame: Day 1
Average inhibition (in percent) following paired auditory stimuli.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average eye blink sum
Time Frame: Day 1
Average eye blink sum (in millivolts) following auditory stimuli.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MindTension

Collaborators

Carmel Medical Center

Investigators

  • Study Director: Hadas Shatz Azoulay, PhD, MindTension

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Actual)

September 15, 2024

Study Completion (Actual)

September 15, 2024

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

November 23, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 23, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MND-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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