Intervertebral Disc DegenerationNCT02873182
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
A study testing Autonomic nervous system monitoring in people with Intervertebral Disc Degeneration and Intervertebral Disc Displacement, run by Stanley Skinner.
Trial summary
A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to assess autonomic neural function during spinal and/or pelvic surgery in women and men. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures
- What is being tested?
- Autonomic nervous system monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥ 18 years of age
- Patients are undergoing lumbar spine surgical and/or pelvic procedure at Abbott Northwestern Hospital
- Patients must be capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed.
Who cannot join
- Patients ≥ 70 years of age
- Patients with obvious groin infection and/or herniation
- Patients with ongoing psychiatric concerns
Trial locations and contacts
No sites are listed yet.
About this study
A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to assess autonomic neural function during spinal and/or pelvic surgery in women and men.
Read the detailed description
This is a safety and efficacy trial to assess autonomic neural function monitoring during spinal and/or pelvic surgery.
During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from individual patients. Throughout the duration of the spinal surgery, the neurophysiologist will continuously monitor autonomic function. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.
EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. The success rates of 1) credible and safe EMG recording and 2) positive EMG responses to each stimulation method will be calculated.
- Conditions
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Stenosis, Spondylitis, Spondylosis
- Being tested
- Autonomic nervous system monitoring
- Keywords
- Intraoperative monitoring, Intraoperative neuromonitoring, Autonomic nervous system, Spine surgery, Pelvic surgery, Sexual function, Bowel function, Bladder function
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Stenosis, Spondylitis, Spondylosis, Osteoarthropathy, Primary Hypertrophic, Spinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic nervous system monitoringDevice
Two intracorporal electrode needles will be inserted beneath the skin of the genitalia. After insertion, the electrodes will be secured and connected by leads to two standard neurophysiological devices for differential amplification, display, and storage. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Autonomic nervous system monitoring | Experimental | During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from all patients who consent to participate in the study. EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. Receives: Device: Autonomic nervous system monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions.
Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency, will be recorded.
Measured: Duration of surgery
Secondary outcomes (2)
Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings.
Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency in response to IOMN (intraoperative neuromonitoring) stimulations and recordings, will be recorded.
Measured: Duration of Surgery
The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.
Measured: Duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanley Skinner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stanley Skinner, Allina Health System
- Investigators
- Nilanjana Banerji, MS, PhD, Study director, Allina Health SystemStanley Skinner, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873182
- Sponsor's protocol ID
- NSSS-1601
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
- ClinicalTrials.gov ID
- NCT02873182
- Acronym / sponsor ID
- NSSS-1601
- Conditions
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Stenosis, Spondylitis, Spondylosis
- Keywords
- Intraoperative monitoring, Intraoperative neuromonitoring, Autonomic nervous system, Spine surgery, Pelvic surgery, Sexual function, Bowel function, Bladder function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanley SkinnerUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 Aug 2016 (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.
A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to assess autonomic neural function during spinal and/or pelvic surgery in women and men.
Detailed description
This is a safety and efficacy trial to assess autonomic neural function monitoring during spinal and/or pelvic surgery.
During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from individual patients. Throughout the duration of the spinal surgery, the neurophysiologist will continuously monitor autonomic function. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.
EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. The success rates of 1) credible and safe EMG recording and 2) positive EMG responses to each stimulation method will be calculated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autonomic nervous system monitoring | Experimental | Device: Autonomic nervous system monitoringDuring standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from all patients who consent to participate in the study. EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be ≥ 18 years of age
- Patients are undergoing lumbar spine surgical and/or pelvic procedure at Abbott Northwestern Hospital
- Patients must be capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed.
Key exclusion criteria (3 listed)
- Patients ≥ 70 years of age
- Patients with obvious groin infection and/or herniation
- Patients with ongoing psychiatric concerns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autonomic nervous system monitoringTwo intracorporal electrode needles will be inserted beneath the skin of the genitalia. After insertion, the electrodes will be secured and connected by leads to two standard neurophysiological devices for differential amplification, display, and storage. Smooth muscle free-running (continuous) and stimulated EMG will be recorded. | Device | Autonomic nervous system monitoring |
Primary outcome
Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions.
Time frame: Duration of surgery
Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency, will be recorded.
2 secondary outcomes
Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings.
Time frame: Duration of Surgery
The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.
Time frame: Duration of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Nilanjana Banerji, MS, PhD study director
Allina Health System
Stanley Skinner, MD principal investigator
Allina Health System
Questions about this trial
What is this clinical trial studying?
A study testing Autonomic nervous system monitoring in people with Intervertebral Disc Degeneration and Intervertebral Disc Displacement, run by Stanley Skinner.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Lintelmann, MPH (612/863-5413, Anna.Lintelmann@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude and frequency of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions. (time frame: Duration of surgery). 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 19 Aug 2016.