Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns

This study is currently recruiting participants.
Verified November 2013 by Lahey Clinic
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00696501
First received: June 10, 2008
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to collect data while monitoring muscles and nerves during spine surgery. The data being collected and analyzed will be used to learn more about how the body's nerves and muscles are distributed and develop a map of human muscle innervation patterns.


Condition
Spine Surgery
Neuromuscular Mapping
Neurodiagnostics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Build a database of spinal nerve root innervation utilizing direct nerve root stimulation [ Time Frame: Data collected during surgery and a 30 day post-op visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare clinical symptoms of the patient to the direct muscle activation via spinal nerve root stimulation [ Time Frame: Data collected during surgery and a 30 day post-op visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2006
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

In this large scale study it is proposed to examine root-to-muscle innervation directly, using the standard Intra-Operative Monitoring procedures during scheduled cervical and lumbar spinal surgeries. The study would directly map muscle and sensory distributions of nerve root innervations with no additional risk to patients.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All neurosurgical patients will be screened for potential eligibility from the Neurosurgery Department's Clinical and operative schedules.

Criteria

Inclusion Criteria:

  • Patients undergoing either cervical or lumbar cord procedures at Lahey Clinic and during which the surgeon has requested intra-operative neurophysiologic monitoring.
  • Surgery performed by a neurosurgeon
  • Participant must be ≥ 18 years of age or ≤ 85 years of age
  • Participant, or legally authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the Lahey Clinic IRB

Exclusion Criteria:

Past medical history significant for any of the following:

  • Peripheral Neuropathy
  • Patients with Diabetes Mellitus
  • Neuromuscular disease that would interfere with intra-operative recordings
  • The Investigator determines that the patient should not be included in the study for reason(s) not already specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696501

Contacts
Contact: Subu N. Magge, M.D. 781-744-3956
Contact: Christine A. Gould, PA 781-744-3956 Christine.A.Gould@Lahey.org

Locations
United States, Massachusetts
Neurosurgery Department, Lahey Clinic, Inc. Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Subu N Magge, M.D.    781-744-3956      
Contact: Christine A. Gould, PA    781-744-3956    Christine.A.Gould@Lahey.org   
Principal Investigator: Subu Magge, MD         
Principal Investigator: Jay Shils, PhD         
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Subu N. Magge, M.D. Lahey Clinic, Inc.
  More Information