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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
  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 ]

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 ]

Enrollment: 203
Study Start Date: May 2006
Study Completion Date: December 2016
Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696501


Locations
United States, Massachusetts
Neurosurgery Department, Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Subu N. Magge, M.D. Lahey Clinic, Inc.
  More Information

Publications:
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00696501     History of Changes
Other Study ID Numbers: 2006-039
First Submitted: June 10, 2008
First Posted: June 12, 2008
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by Lahey Clinic:
Neuromuscular mapping
Spinal surgery
Neurodiagnostics
Segmental root innervation
Dermatomal innervation
Myotomal innervation
Nerve roots
Sensory
Signs and Symptoms