NCT06707415

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
Last Updated

November 27, 2024

Status Verified

June 1, 2024

Enrollment Period

11 days

First QC Date

September 18, 2024

Last Update Submit

November 23, 2024

Conditions

ElectromyographyAuditory Event-related Potential (AERP)

Keywords

MT1ElectromyographyAuditory evoked potentials

Outcome Measures

Primary Outcomes (4)

  • Average maximal peak levels

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

    Day 1

  • Average peak index

    The average index (in milliseconds) following auditory stimulus.

    Day 1

  • Average eye blink width

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

    Day 1

  • Average inhibition

    Average inhibition (in percent) following paired auditory stimuli.

    Day 1

Secondary Outcomes (1)

  • Average eye blink sum

    Day 1

Study Arms (1)

EMG evaluated group

EXPERIMENTAL

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

Diagnostic Test: Auditory evoked potentials

Interventions

Auditory evoked potentialsDIAGNOSTIC_TEST

Auditory evoked potentials in parallel systems

EMG evaluated group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject's informed consent.
  • Healthy subjects, with no known chronic disease.
  • Both genders, age between 18-45.

You may not qualify if:

  • Any current co-morbid Chronic illness.
  • Hearing loss.
  • Pregnancy.
  • Substance abuse during the last 3 months.
  • Lack of cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Interventions

Evoked Potentials, Auditory

Intervention Hierarchy (Ancestors)

Evoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological PhenomenaVestibulocochlear Physiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hadas Shatz Azoulay, PhD

    MindTension

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2024

First Posted

November 27, 2024

Study Start

September 4, 2024

Primary Completion

September 15, 2024

Study Completion

September 15, 2024

Last Updated

November 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)