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

Terminated

• Conditions: Spine Surgery; Neuromuscular Mapping; Neurodiagnostics

• Registration Number: NCT00696501
• Lead Sponsor: Lahey Clinic

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 muscles are distributed and develop a map of human muscle innervation patterns.

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Build a database of spinal nerve root innervation utilizing direct nerve root stimulation	Data collected during surgery and a 30 day post-op visit

Secondary Outcome Measures

Name	Time	Method
Compare clinical symptoms of the patient to the direct muscle activation via spinal nerve root stimulation	Data collected during surgery and a 30 day post-op visit

Trial Locations

Locations (1)

Neurosurgery Department, Lahey Clinic, Inc.; 🇺🇸 Burlington, Massachusetts, United States