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

August 16, 2016 updated by: Stanley Skinner
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duration of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Duration of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanley Skinner

Investigators

  • Study Director: Nilanjana Banerji, MS, PhD, Allina Health
  • Principal Investigator: Stanley Skinner, MD, Allina Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSSS-1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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