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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00696501

Enrollment

203

Registered

2008-06-12

Start date

2006-05-31

Completion date

2016-12-31

Last updated

2017-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodiagnostics, Neuromuscular Mapping, Spine Surgery

Keywords

Neuromuscular mapping, Spinal surgery, Neurodiagnostics, Segmental root innervation, Dermatomal innervation, Myotomal innervation, Nerve roots, Sensory, Signs and Symptoms

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results