Clinical trial NCT02630576: Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy (Volunteers
Official title: Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electromyography
Neuromuscular Monitoring
Keywords: electromyography
neuromuscular blockade
Lead sponsor: University of Debrecen
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary performance assessment of TetraGraph device
timeFrame: Subjects will be followed for the time of measurements an expected avarage of one hour
Secondary outcomes:
measure: Secondary performance assessment of TetraGraph Device
timeFrame: Subjects will be followed for the time of measurements an expected avarage of one hour
Other outcomes:
measure: Safety assessment of TetraGraph device
timeFrame: Subjects will be followed for the time of measurements an expected avarage of one hour
Locations:
city: Debrecen
country: Hungary
facility: University of Debrecen
Study officials:
affiliation: UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032
name: Bela Fulesdi, MD,PhD,DSci
role: PRINCIPAL_INVESTIGATOR
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