ElectromyographyNCT06707415
Compare the Accuracy of MindTension Blink Eye Reflex Measuring Device to DANTAC Keypoint Electromyography (EMG) System.
A study testing Auditory evoked potentials in people with Electromyography and Auditory Event-related Potential (AERP), run by MindTension at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Electromyography, Auditory Event-related Potential (AERP)
- What is being tested?
- Auditory evoked potentials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Sep 2024to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject's informed consent.
- Healthy subjects, with no known chronic disease.
- Both genders, age between 18-45.
Who cannot join
- Any current co-morbid Chronic illness.
- Hearing loss.
- Pregnancy.
- Substance abuse during the last 3 months.
- Lack of cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the 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.
- Being tested
- Auditory evoked potentials
- Keywords
- MT1, Electromyography, Auditory evoked potentials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory evoked potentialsDiagnostic test
Auditory evoked potentials in parallel systems
| Study group | Role | What they receive |
|---|---|---|
| EMG evaluated group | Experimental | Participants are evaluated in both the MT1 and the Natus Dantec Keypoint systems Receives: Diagnostic Test: Auditory evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average maximal peak levels
The average peak levels (in millivolts) following auditory stimulus.
Measured: Day 1
Average peak index
The average index (in milliseconds) following auditory stimulus.
Measured: Day 1
Average eye blink width
Average eye blink width (in milliseconds) following auditory stimuli.
Measured: Day 1
Average inhibition
Average inhibition (in percent) following paired auditory stimuli.
Measured: Day 1
Secondary outcomes (1)
Average eye blink sum
Average eye blink sum (in millivolts) following auditory stimuli.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start4 Sep 2024
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectromyographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- MindTension
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carmel Medical Center
- Responsible party
- Sponsor
- Investigators
- Hadas Shatz Azoulay, PhD, Study director, MindTension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707415
- Sponsor's protocol ID
- MND-03
- Status last verified
- Jun 2024
- First submitted
- 18 Sep 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06707415
- Acronym / sponsor ID
- MND-03
- Keywords
- MT1, Electromyography, Auditory evoked potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- MindTensionIndustry (pharma, biotech, devices)
- Collaborators
- Carmel Medical Center
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMG evaluated group | Experimental | Diagnostic Test: Auditory evoked potentialsParticipants are evaluated in both the MT1 and the Natus Dantec Keypoint systems |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject's informed consent.
- Healthy subjects, with no known chronic disease.
- Both genders, age between 18-45.
Key exclusion criteria (5 listed)
- Any current co-morbid Chronic illness.
- Hearing loss.
- Pregnancy.
- Substance abuse during the last 3 months.
- Lack of cooperation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory evoked potentialsAuditory evoked potentials in parallel systems | Diagnostic test | EMG evaluated group |
Primary outcome
Average maximal peak levels
Time frame: Day 1
The average peak levels (in millivolts) following auditory stimulus.
Average peak index
Time frame: Day 1
The average index (in milliseconds) following auditory stimulus.
Average eye blink width
Time frame: Day 1
Average eye blink width (in milliseconds) following auditory stimuli.
Average inhibition
Time frame: Day 1
Average inhibition (in percent) following paired auditory stimuli.
1 secondary outcome
Average eye blink sum
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadas Shatz Azoulay, PhD study director
MindTension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory evoked potentials in people with Electromyography and Auditory Event-related Potential (AERP), run by MindTension at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average maximal peak levels (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.