Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns - Full Text View

Sponsored by:	Lahey Clinic
Information provided by:	Lahey Clinic
ClinicalTrials.gov Identifier:	NCT00696501

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2011 (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
Sub-Investigator: G. Rees Cosgrove, M.D.
Sub-Investigator: Peter Dempsey, M.D.
Sub-Investigator: Jeffrey Arle, M.D., Ph.D.
Sub-Investigator: Carlos David, M.D.
Sub-Investigator: Edward Tarlov, M.D.
Sub-Investigator: Jay Shils, Ph.D.
Sub-Investigator: Stefan Kim, M.D.
Sub-Investigator: Carl Felz, CINM, DABNM
Sub-Investigator: Marina Moul, BS

Sponsors and Collaborators

Lahey Clinic

Investigators

Principal Investigator:

Subu N. Magge, M.D.

Lahey Clinic, Inc.

More Information

Publications:

Dykes RW, Terzis JK. Spinal nerve distributions in the upper limb: the organization of the dermatome and afferent myotome. Philos Trans R Soc Lond B Biol Sci. 1981 Aug 12;293(1070):509-54.

Tsao BE, Levin KH, Bodner RA. Comparison of surgical and electrodiagnostic findings in single root lumbosacral radiculopathies. Muscle Nerve. 2003 Jan;27(1):60-4.

Levin KH, Maggiano HJ, Wilbourn AJ. Cervical radiculopathies: comparison of surgical and EMG localization of single-root lesions. Neurology. 1996 Apr;46(4):1022-5.

Møller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7. No abstract available.

Bose B, Sestokas AK, Schwartz DM. Neurophysiological monitoring of spinal cord function during instrumented anterior cervical fusion. Spine J. 2004 Mar-Apr;4(2):202-7.

MacDonald DB. Safety of intraoperative transcranial electrical stimulation motor evoked potential monitoring. J Clin Neurophysiol. 2002 Oct;19(5):416-29. Review.

Responsible Party:	Lahey Clinic, Inc. ( Subu Magge, M.D. )
Study ID Numbers:	2006-039
Study First Received:	June 10, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00696501
Health Authority:	United States: Institutional Review Board

Keywords provided by Lahey Clinic:

Neuromuscular mapping
Spinal surgery
Neurodiagnostics
Segmental root innervation
Dermatomal innervation

Myotomal innervation
Nerve roots
Sensory
Signs and Symptoms

Study placed in the following topic categories:

Signs and Symptoms

ClinicalTrials.gov processed this record on January 15, 2009