Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy (Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy Volunteers

Conditions
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Electromyography, Neuromuscular Monitoring

Intervention / Treatment
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* Device: Neuromuscular stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Men - Left Hand<br>5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand | Device: Neuromuscular stimulation<br>* Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity<br>|
| Experimental: Men - Right Hand<br>5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand | Device: Neuromuscular stimulation<br>* Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity<br>|
| Experimental: Women - Left Hand<br>5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand | Device: Neuromuscular stimulation<br>* Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity<br>|
| Experimental: Women - Right Hand<br>5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand | Device: Neuromuscular stimulation<br>* Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary performance assessment of TetraGraph device | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary performance assessment of TetraGraph Device | 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 | Subjects will be followed for the time of measurements an expected avarage of one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electromyography, neuromuscular blockade