Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy (Volunteers (NEAT-2)

March 8, 2017 updated by: Tamas Vegh, MD, University of Debrecen

Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy Volunteers

TetraGraph is a newly developed EMG-based (electromyograph), quantitative, battery-powered neuromuscular monitoring system intended for daily clinical use. The primary aim of this clinical investigation is to examine the applicability (ease of use, equipment need, etc.), repeatability (precision or internal consistency) and performance (signal quality, accuracy of outcome, voltage of stimulation output before and during a stimulus) and tolerability of the Tetragraph device in healthy volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary endpoint will be assessment of the ability of the TetraGraph prototype to deliver neuro-stimulation, and assessment of the ability to acquire muscle action potentials and record these evoked responses on the SD-card. The study will be performed on healthy volunteers - 10 male and 10 female. Testing will be done at two separate stimulation/recording sites: ulnar nerve stimulation/abductor digiti minimi (ADM) muscle recording; and ulnar nerve stimulation/adductor pollices (AP) muscle recording. The side of testing (RIGHT vs. LEFT hand) will be determined a priori and randomly by the principal investigator, such that 10 volunteers each will be tested on the RIGHT and 10 on the LEFT hands. At each stimulating/recording site two stimulation protocols (single twitch stimulation and train-of-four stimulation) will be performed with growing current intensity (10-60 mA (milliAmps), in a 10 mA step-up fashion). Volunteers will rate the tolerability of each stimulation protocols on a visual analogue scale. EMG data will be recorded on the SD card and evaluated off-line.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Hungary
      • Debrecen, Hungary, 4032
        • University of Debrecen

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older
  • Volunteer is American Society of Anesthesiology (ASA) physical status I-III (Tabl
  • Volunteer has provided written informed consent

Exclusion Criteria:

  • Presence of an underlying neuromuscular disease
  • Use of medications known to interfere with neuromuscular transmission
  • Presence of renal or hepatic disease
  • Subject has only one upper extremity
  • Subject has open sores at the skin sites needed for electrode application

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Men - Left Hand
5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand
Device: Neuromuscular stimulation
Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity
Experimental: Men - Right Hand
5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand
Device: Neuromuscular stimulation
Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity
Experimental: Women - Left Hand
5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand
Device: Neuromuscular stimulation
Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity
Experimental: Women - Right Hand
5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand
Device: Neuromuscular stimulation
Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary performance assessment of TetraGraph device
Time Frame: Subjects will be followed for the time of measurements an expected avarage of one hour
The primary objective of this study is the assessment of the ability of the prototype to deliver neuro-stimulation, and assessment of the ability to acquire muscle action potentials and record these evoked responses on the SD-card.
Subjects will be followed for the time of measurements an expected avarage of one hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary performance assessment of TetraGraph Device
Time Frame: Subjects will be followed for the time of measurements an expected avarage of one hour

The secondary outcome measures is a composite of several performance data:

  1. Confirmation that the prototype can independently stimulate and record repetitive patterns of neuro-stimulation (1 Hz ST and TOF);
  2. Verify that stimulus artifact will not exceed 2.0 mV( millivolt), nor overlap with the evoked EMG response when a stimulus is applied;
  3. Validate the consistency of delivered stimuli, assessed by repeatability of evoked responses.
  4. Verify delivery of neuro-stimulation at varying currents, from the lowest current that produces an evoked response to the current above which the evoked response no longer increases, at increasing current levels separated by steps of 10 mA;
  5. Determine any difference in recording performance using evoked responses (1 Hz ST, TOF) between recordings at two different hand muscles, the abductor digiti minimi and adductor pollices muscles;
  6. Document consistency of stimulation at constant currents independent of patient age, sex, handedness or
Subjects will be followed for the time of measurements an expected avarage of one hour

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety assessment of TetraGraph device
Time Frame: Subjects will be followed for the time of measurements an expected avarage of one hour
The safety of Tetragraph device will be assesses by checking the stimulating and recording electrode positions for skin reactions and by establishing the discomfort, if any, associated with nerve stimulation in awake, un-medicated human volunteers. Assessment will be made using an 11-point visual analog score (VAS) scale, anchored with 0 (representing no distress) and 10 (representing the worst distress ever experienced) (Table I). These VAS scores will be compared to those reported in the literature.
Subjects will be followed for the time of measurements an expected avarage of one hour

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Debrecen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bela Fulesdi, MD,PhD,DSci, UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADBV-ABS-0214-NEAT-2H
  • 028605-010/2014/OTIG (Registry Identifier: The Office for Health Authorization and Administrative Procedures (EEKH))
  • DE RKEB/IKEB4170-2014 (Registry Identifier: Regional and Institutional Ethics Committee, university of Debrecen)

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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