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

NCT02873182 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-08-19

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Stanley Skinner

    lead OTHER

Principal Investigators

  • Nilanjana Banerji, MS, PhD · Allina Health

  • Stanley Skinner, MD · Allina Health

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-08-31
Completion
2018-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02873182 on ClinicalTrials.gov