NCT02873182

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

August 10, 2016

Last Update Submit

August 16, 2016

Conditions

Intervertebral Disc DegenerationIntervertebral Disc DisplacementSpinal CurvaturesSpinal StenosisSpondylitisSpondylosisOsteoarthropathy, Primary HypertrophicSpinal Neoplasms

Keywords

Intraoperative monitoringIntraoperative neuromonitoringAutonomic nervous systemSpine surgeryPelvic surgerySexual functionBowel functionBladder function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Amplitude and frequency of changes in smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulations and recordings.

    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.

    Duration of surgery

Study Arms (1)

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.

Device: Autonomic nervous system monitoring

Interventions

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.

Autonomic nervous system monitoring

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients ≥ 70 years of age
  • Patients with obvious groin infection and/or herniation
  • Patients with ongoing psychiatric concerns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc DegenerationIntervertebral Disc DisplacementSpinal CurvaturesSpinal StenosisSpondylitisSpondylosisOsteoarthropathy, Primary HypertrophicSpinal Neoplasms

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBone Diseases, InfectiousInfectionsJoint DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBone NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Nilanjana Banerji, MS, PhD

    Allina Health

    STUDY DIRECTOR

  • Stanley Skinner, MD

    Allina Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Lintelmann, MPH

CONTACT

612/863-5413Anna.Lintelmann@allina.com

Amy Schrecengost, BS

CONTACT

612/863-6562Amy.Schrecengost@allina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neurophysiologist

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 19, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 19, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share