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ElectromyographyNEAT-2NCT02630576

Neurostimulation and Electromyographs Assessment of th TetraGraph in Healthy (Volunteers

A study testing Neuromuscular stimulation in people with Electromyography and Neuromuscular Monitoring, run by University of Debrecen at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Electromyography, Neuromuscular Monitoring
What is being tested?
Neuromuscular stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteHungary
Study dates
Jun 2015to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older
  • Volunteer is American Society of Anesthesiology (ASA) physical status I-III (Tabl
  • Volunteer has provided written informed consent

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Hungary1 site

  • University of Debrecen

    Debrecen, 4032

Other trials in Hungary

About this study

Official title: 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.

Read the 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.

Being tested
Neuromuscular stimulation
Keywords
electromyography, neuromuscular blockade

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular stimulationDevice

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

Study groups in NCT02630576
Study groupRoleWhat they receive
Men - Left HandExperimental5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand
Receives: Device: Neuromuscular stimulation
Men - Right HandExperimental5 healthy male volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand
Receives: Device: Neuromuscular stimulation
Women - Left HandExperimental5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the left hand
Receives: Device: Neuromuscular stimulation
Women - Right HandExperimental5 healthy female volunteers undergoing 4 types of neuromuscular stimulation protocols on the right hand
Receives: Device: Neuromuscular stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Subjects will be followed for the time of measurements an expected avarage of one hour

Secondary outcomes (1)

  1. Secondary performance assessment of TetraGraph Device

    The secondary outcome measures is a composite of several performance data:

    1. Confirmation that the prototype can independently stimulate and record repetitive patterns of neuro-stimulation (1 Hz ST and TOF);
    2. Verify that stimulus artifact will not exceed 2.0 mV( millivolt), nor overlap with the evoked EMG response when a stimulus is applied;
    3. Validate the consistency of delivered stimuli, assessed by repeatability of evoked responses.
    4. 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;
    5. 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;
    6. Document consistency of stimulation at constant currents independent of patient age, sex, handedness or

    Measured: Subjects will be followed for the time of measurements an expected avarage of one hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02630576
Sponsor's protocol ID
ADBV-ABS-0214-NEAT-2H
Other IDs
028605-010/2014/OTIG, DE RKEB/IKEB4170-2014
Acronym
NEAT-2
Status last verified
Mar 2017
First submitted
22 May 2015
Last updated
9 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11942873

  • 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.

    PubMed 16428537

  • 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.

    PubMed 12456433

  • 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.

    PubMed 18635478

  • 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.

    PubMed 20442260

  • 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.

    PubMed 17197470

  • 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.

    PubMed 8394051

  • 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.

    PubMed 17635429

  • 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.

    PubMed 18497614

  • 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.

    PubMed 2160781

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular stimulation in people with Electromyography and Neuromuscular Monitoring, run by University of Debrecen at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary performance assessment of TetraGraph device (time frame: Subjects will be followed for the time of measurements an expected avarage of one hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02630576, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.

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