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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02873182
• Other study ID #: NSSS-1601
• Status: Not yet recruiting
• Phase: N/A
• First received: August 10, 2016
• Last updated: August 16, 2016
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2016
• Source: Allina Health System
• Contact: Anna Lintelmann, MPH
• Phone: 612/863-5413
• Email: Anna.Lintelmann[@]allina.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypertrophy
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Osteoarthropathy, Primary Hypertrophic
• Spinal Curvatures
• Spinal Neoplasms
• Spinal Stenosis
• Spondylitis
• Spondylosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Skinner

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Duration of surgery	Yes
Secondary	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.	Duration of Surgery	Yes
Secondary	The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.		Duration of surgery	Yes