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Completed

NCT Number: NCT02630576

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.

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Key information

Conditions

Electromyography Neuromuscular Monitoring

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Debrecen

Debrecen, 4032, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Neuromuscular stimulation

Device

Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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:

    • Confirmation that the prototype can independently stimulate and record repetitive patterns of neuro-stimulation (1 Hz ST and TOF);
    • Verify that stimulus artifact will not exceed 2.0 mV( millivolt), nor overlap with the evoked EMG response when a stimulus is applied;
    • Validate the consistency of delivered stimuli, assessed by repeatability of evoked responses.
    • 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;
    • 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;
    • Document consistency of stimulation at constant currents independent of patient age, sex, handedness or

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Debrecen

Other

Registry information

Official study title

Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy Volunteers

Acronym: NEAT-2

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 15, 2015
Registry last updated
Mar 9, 2017

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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