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

This study has been terminated.
(One of the investigators left the Institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00696501
First Posted: June 12, 2008
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lahey Clinic
June 10, 2008
June 12, 2008
August 24, 2017
May 2006
December 2016   (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 ]
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 ]
Same as current
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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.
 
Terminated
203
December 2016
December 2016   (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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00696501
2006-039
No
Not Provided
Not Provided
Lahey Clinic
Lahey Clinic
Not Provided
Principal Investigator: Subu N. Magge, M.D. Lahey Clinic, Inc.
Lahey Clinic
August 2017