Degenerative Lumbar Disc DiseaseNCT02192112
Advanced XLIF Monitoring Pilot Study
An observational study of Degenerative Lumbar Disc Disease, run by NuVasive at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Lumbar Disc Disease
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to 8 May 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At least 20 subjects will be consecutively enrolled in this prospective pilot study from up to three (3) participating centers. Patients who, in the surgeon investigator's opinion, require lateral approach spinal fusion surgery at spinal level L4-5 (though may include any number of levels from L2 through L5), and have consented to XLIF surgery for their condition will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Durango Orthopaedics Associates/Spine Colorado
Durango, Colorado, 81301
Pinnacle Orthopaedics & Sports Medicine Specialists
Marrietta, Georgia, 30060
About this study
Official title: Evaluation of Transcutaneous Stimulation of Lumbosacral Nerve Roots: A 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.
- Conditions
- Degenerative Lumbar Disc Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.
Measured: Intraoperative
Secondary outcomes (3)
Correlation of any observed changes in the response or response thresholds with surgical events.
Measured: Intraoperative
Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.
Measured: Intraoperative
Correlation between observed changes in the response or response threshold and postoperative neural status.
Measured: 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2014
- Primary completion8 May 2018
- Study completion8 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Malone, MS, Study director, NuVasive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192112
- Sponsor's protocol ID
- NUVA.NV1301
- Status last verified
- Dec 2025
- First submitted
- 1 Jul 2014
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transcutaneous Stimulation of Lumbosacral Nerve Roots: A Pilot Study
- ClinicalTrials.gov ID
- NCT02192112
- Acronym / sponsor ID
- NUVA.NV1301
- Conditions
- Degenerative Lumbar Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At least 20 subjects will be consecutively enrolled in this prospective pilot study from up to three (3) participating centers. Patients who, in the surgeon investigator's opinion, require lateral approach spinal fusion surgery at spinal level L4-5 (though may include any number of levels from L2 through L5), and have consented to XLIF surgery for their condition will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery.
Time frame: Intraoperative
3 secondary outcomes
Correlation of any observed changes in the response or response thresholds with surgical events.
Time frame: Intraoperative
Correlation between patient characteristics and the ability to generate and reliably record responses and response thresholds.
Time frame: Intraoperative
Correlation between observed changes in the response or response threshold and postoperative neural status.
Time frame: 6 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Malone, MS study director
NuVasive
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Disc Disease, run by NuVasive at 2 sites in United States.
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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Reproducibility of obtaining reliable responses and response thresholds monitored over the course of surgery. (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025.