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Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in Lumbar Radiculopathy.

NCT02185508 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2014-07-09

No results posted yet for this study

Summary

The purpose of this study is to determine the relation among: (1) changes in voltage and amplitude of trans-operatory records obtained through the use of Intra-operative Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1 or 2 levels surgical decompression at lumbar spine.

IONM is the use of real time neurophysiological techniques during spinal surgeries. The modalities included in this study are:

* Somatosensory evoked potentials (SSEPs).
* Trans-cranial electric motor evoked potentials (tceMEPs).
* Spontaneous electromyography (EMG).

Clinical outcome of the patients will be assessed through a careful evaluation of clinical data, as well as the application of three outcome scales:

* Oswestry Disability Index 2.1a
* Visual Analogue Scale for Pain
* Patient's Overall Impression of Change

Conditions

  • Lumbar Disc Disease

Sponsors & Collaborators

  • American British Cowdray Medical Center

    lead OTHER

Principal Investigators

  • Roberto De Leo Vargas, MD · American British Cowdray Medical Center

  • Maximino Tellez, MD · American British Cowdray Medical Center

  • Ildefonso Muñoz Romero, MD · American British Cowdray Medical Center

  • Miguel Angel Collado Corona, MD · American British Cowdray Medical Center

  • Leopoldo Torres Vyera, MD · American British Cowdray Medical Center

  • Christian Cerecedo, MD · American British Cowdray Medical Center

  • Eduardo Galvan Hernandez, MD · American British Cowdray Medical Center

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02185508 on ClinicalTrials.gov