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Completed No phase listed Observational

Determination of TOF Test Threshold for Obtaining Reliable Pedicle Screw Stimulation Test During Lumbar Spine Surgery

ClinicalTrials.gov ID: NCT02285829

Public ClinicalTrials.gov record NCT02285829. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:25 AM EDT

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

During lumbar spine fusion surgery intraoperative neurophysiological monitoring is in routine use for prevention of possible nerve injuries during placement of screw into pedicle. Pedicle screw stimulation test is performed to assess if screw placement is encroaching on the nerve roots. Relative distance between the pedicle screw and the neighbouring root can be estimated by the intensity of the current required to activate the root and appropriate muscle. A properly placed screw can be distinguished from those perforating the pedicle wall by its higher minimum level of electrical current needed to elicit a muscle response. The minimum level is deemed as threshold. This test is based on compound muscle action potential (CMAP) and use of neuromuscular blocking agents (NMBA) should be avoided because of possible cause of false negative results of screw stimulation test. Neuromuscular blocking agents, which are in routine use during anesthesia, will have effect on muscle action potential. When NMBA are used current stimulus will depolarize the same number of axons and the associated muscle response will be present but of lower amplitude because some percentage of motor fibers will be blocked by activity of NMBA. At this point, stronger stimulus is needed to recruit additional axons/muscle fibers , and hence, the measured threshold is elevated. Train of four (TOF) test is method used to determine level of neuromuscular blockade, by stimulation of peripheral nerve and following induced muscle contractions. Interpretation of muscle contractions may be by subjective (visual) or objective (quantitative) method. Quantitative TOF test may be used prior screw stimulation test by calculating T4/T1 ratio and obtaining quantitative value which shows level of neuromuscular blockade. Residual neuromuscular blockade may be present before screw stimulation test, and effect on accuracy of this test in this situation was not clearly investigated in recent studies. The purpose of this study would be to determine changes of screw stimulation thresholds under different range of neuromuscular blockade.Therefore, acceptable neuromuscular blockade threshold (determined by TOF test) acceptable for obtaining reliable screw stimulation test should be determined. Screw stimulation test may be performed when neuromuscular blockade is absent and compared to repeated screw stimulation test when neuromuscular blockade is present. Different levels of neuromuscular blockade may provide different results on screw stimulation test, so if difference is statistically significant, induced neuromuscular blockade level may be set as threshold value, acceptable for obtaining reliable testing results.

Study identification

NCT ID
NCT02285829
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
NYU Langone Health
Other
Enrollment
46 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 10, 2015
Primary completion
Jan 7, 2018
Completion
Jan 7, 2018
Last update posted
Jan 17, 2018

2015 – 2018

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
NYU Langone Medical Center, Hospital for Joint Diseases New York New York 10003

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02285829, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 17, 2018 · Synced Sep 5, 2026

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Open the official record

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