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

Lahey Clinic203 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

203

Conditions

Spine Surgery Neuromuscular Mapping Neurodiagnostics

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Neurosurgery Department, Lahey Clinic, Inc.

Burlington, Massachusetts, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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