NCT02533024

Brief Summary

This study is to investigate the incidence of undiagnosed ulnar neuropathy in patients undergoing surgery. The investigators hope to determine if patients with ulnar neuropathy have changes in nerve conduction latency during surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

August 20, 2015

Last Update Submit

September 21, 2017

Conditions

Ulnar Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Prevalence of ulnar neuropathy in patients scheduled to undergo anesthesia and surgery as measured by electromyography

    Prevalence of undiagnosed or subclinical ulnar neuropathy as determined by electromyography

    Day 1

Secondary Outcomes (3)

  • Amplitude (mV)

    Day 1

  • Latency (ms)

    Day 1

  • Velocity (m/s)

    Day 1

Study Arms (1)

Group Cohort

EXPERIMENTAL

All subjects will have nerve conduction studies (Electromyography/EMG) pre-operatively, monitored intra-operatively and immediately post-operative.

Other: Electromyography

Interventions

ElectromyographyOTHER

All subjects will have an EMG before, during and immediately after surgery.

Also known as: EMG
Group Cohort

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs of age or older
  • Scheduled to undergo a surgical procedure at UTMC with an anticipated length of 2hours or greater

You may not qualify if:

  • Less than 50yrs
  • Not scheduled for a surgical procedure at UTMC or scheduled for a surgical procedure with an anticipated length of less than 2hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toledo

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Ulnar Neuropathies

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Andrew B Casabianca, MD

    University of Toledo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 26, 2015

Study Start

August 1, 2015

Primary Completion

April 28, 2017

Study Completion

April 28, 2017

Last Updated

September 25, 2017

Record last verified: 2016-09

Locations

US(1)