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

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: Completed
• Conditions: Neuromuscular Monitoring; Electromyography
• Intervention / Treatment: Device: Neuromuscular stimulation

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment of TetraGraph device	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

• Sponsor: University of Debrecen
• Investigators: 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

General Publications

• Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
• Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f.
• Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.
• Grayling M, Sweeney BP. Recovery from neuromuscular blockade: a survey of practice. Anaesthesia. 2007 Aug;62(8):806-9. doi: 10.1111/j.1365-2044.2007.05101.x.
• Gatke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Postoperative muscle paralysis after rocuronium: less residual block when acceleromyography is used. Acta Anaesthesiol Scand. 2002 Feb;46(2):207-13. doi: 10.1034/j.1399-6576.2002.460216.x.
• Kim KS, Lew SH, Cho HY, Cheong MA. Residual paralysis induced by either vecuronium or rocuronium after reversal with pyridostigmine. Anesth Analg. 2002 Dec;95(6):1656-60, table of contents. doi: 10.1097/00000539-200212000-00033.
• Hemmerling TM, Le N. Brief review: Neuromuscular monitoring: an update for the clinician. Can J Anaesth. 2007 Jan;54(1):58-72. doi: 10.1007/BF03021901.
• Brull SJ, Silverman DG. Visual and tactile assessment of neuromuscular fade. Anesth Analg. 1993 Aug;77(2):352-5. doi: 10.1213/00000539-199308000-00024.
• Claudius C, Viby-Mogensen J. Acceleromyography for use in scientific and clinical practice: a systematic review of the evidence. Anesthesiology. 2008 Jun;108(6):1117-40. doi: 10.1097/ALN.0b013e318173f62f.
• Connelly NR, Silverman DG, O'Connor TZ, Brull SJ. Subjective responses to train-of-four and double burst stimulation in awake patients. Anesth Analg. 1990 Jun;70(6):650-3. doi: 10.1213/00000539-199006000-00012.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: electromyography; neuromuscular blockade
• Other Study ID 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)