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Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study

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ClinicalTrials.gov Identifier: NCT02873182
Recruitment Status : Unknown
Verified August 2016 by Stanley Skinner, Allina Health System.
Recruitment status was:  Not yet recruiting
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Stanley Skinner, Allina Health System

Brief 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.

Condition or disease Intervention/treatment Phase
Intervertebral Disc Degeneration Intervertebral Disc Displacement Spinal Curvatures Spinal Stenosis Spondylitis Spondylosis Osteoarthropathy, Primary Hypertrophic Spinal Neoplasms Device: Autonomic nervous system monitoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: Autonomic nervous system monitoring
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.
Device: Autonomic nervous system monitoring
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be ≥ 18 years of age
  2. Patients are undergoing lumbar spine surgical and/or pelvic procedure at Abbott Northwestern Hospital
  3. 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.

Exclusion Criteria:

  1. Patients ≥ 70 years of age
  2. Patients with obvious groin infection and/or herniation
  3. Patients with ongoing psychiatric concerns

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873182


Contacts
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Contact: Anna Lintelmann, MPH 612/863-5413 Anna.Lintelmann@allina.com
Contact: Amy Schrecengost, BS 612/863-6562 Amy.Schrecengost@allina.com

Sponsors and Collaborators
Stanley Skinner
Investigators
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Study Director: Nilanjana Banerji, MS, PhD Allina Health
Principal Investigator: Stanley Skinner, MD Allina Health

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Responsible Party: Stanley Skinner, Neurophysiologist, Allina Health System
ClinicalTrials.gov Identifier: NCT02873182     History of Changes
Other Study ID Numbers: NSSS-1601
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stanley Skinner, Allina Health System:
Intraoperative monitoring
Intraoperative neuromonitoring
Autonomic nervous system
Spine surgery
Pelvic surgery
Sexual function
Bowel function
Bladder function

Additional relevant MeSH terms:
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Spondylitis
Hypertrophy
Spinal Stenosis
Intervertebral Disc Degeneration
Spondylosis
Intervertebral Disc Displacement
Spinal Curvatures
Spinal Neoplasms
Osteoarthropathy, Primary Hypertrophic
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Pathological Conditions, Anatomical
Hernia
Bone Neoplasms
Neoplasms by Site
Neoplasms
Joint Diseases
Genetic Diseases, Inborn