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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Lahey Clinic
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00696501
First received: June 10, 2008
Last updated: June 11, 2014
Last verified: June 2014

June 10, 2008
June 11, 2014
May 2006
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00696501 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns
Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Spine Surgery
  • Neuromuscular Mapping
  • Neurodiagnostics
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
May 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Subu N. Magge, M.D. 781-744-3956
Contact: Christine A. Gould, PA 781-744-3956 Christine.A.Gould@Lahey.org
United States
 
NCT00696501
2006-039
No
Lahey Clinic
Lahey Clinic
Not Provided
Principal Investigator: Subu N. Magge, M.D. Lahey Clinic, Inc.
Lahey Clinic
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP