Status:
TERMINATED
Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns
Lead Sponsor:
Lahey Clinic
Conditions:
Spine Surgery
Neuromuscular Mapping
Eligibility:
All Genders
18-85 years
Brief Summary
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 ...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00696501
Start Date
May 1 2006
End Date
December 1 2016
Last Update
August 24 2017
Active Locations (1)
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1
Neurosurgery Department, Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805