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

University of Debrecen

Status: Completed

Conditions: Neuromuscular Monitoring; Electromyography

Treatments: Device: Neuromuscular stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02630576

DE RKEB/IKEB4170-2014 (Registry Identifier)

028605-010/2014/OTIG (Registry Identifier)

ADBV-ABS-0214-NEAT-2H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Men - Left Hand

Experimental group

Description:

5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand

Treatment:

Device: Neuromuscular stimulation

Men - Right Hand

Experimental group

Description:

5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand

Treatment:

Device: Neuromuscular stimulation

Women - Left Hand

Experimental group

Description:

5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand

Treatment:

Device: Neuromuscular stimulation

Women - Right Hand

Experimental group

Description:

5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand

Treatment:

Device: Neuromuscular stimulation