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Completed

NCT Number: NCT02192112

Advanced XLIF Monitoring Pilot Study

Though the utility of NVM5 neuromonitoring by stimulating within the surgical site during XLIF has been demonstrated, it is hypothesized that more information may be gathered if a greater section of the motor neural pathway was monitored (i.e., stimulation above the surgical site and recording the subsequent muscle response in the lower limbs). Currently, there has not been demonstrated a practical method of stimulating the lumbosacral nerve roots locally, but well-above the surgical site in this fashion.

This protocol is intended to evaluate the feasibility and reproducibility of using surface stimulation and return (anode) electrodes to stimulate the lumbosacral nerve roots, and record responses from the relevant innervated muscle groups of the lower limbs.

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Key information

Conditions

Degenerative Lumbar Disc Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Durango Orthopaedics Associates/Spine Colorado, Durango, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female spine surgery patients who are at least 18 years of age
  • Surgical candidates for lateral approach lumbar spine surgery at spinal levels L2 to L5, inclusive of L4-5
  • Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation

Exclusion criteria

  • Currently undergoing surgical treatment at any spinal level other than L2 to L5, including S1
  • Pregnant women
  • Implanted pacemaker, defibrillator, or other electronic devices
  • Involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
  • Underlying neurological disease or neurological deficit that is not associated with the condition for which he/she is seeking surgical intervention (e.g., diabetic peripheral neuropathy)

Treatment and study plan

Primary outcomes

  1. Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.

    Time frame: Intraoperative

Secondary outcomes

  1. Correlation of any observed changes in the response or response thresholds with surgical events.

    Time frame: Intraoperative

  2. Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.

    Time frame: Intraoperative

  3. Correlation between observed changes in the response or response threshold and postoperative neural status.

    Time frame: 6 weeks postoperative

Sponsors and collaborators

Lead sponsor

NuVasive

Industry

Registry information

Official study title

Evaluation of Transcutaneous Stimulation of Lumbosacral Nerve Roots: A Pilot Study

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2014
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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