Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergoing either cervical or lumbar cord procedures at Lahey Clinic and during which the surgeon has requested intra-operative neurophysiologic monitoring.
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Surgery performed by a neurosurgeon
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Participant must be ≥ 18 years of age or ≤ 85 years of age
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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:
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Peripheral Neuropathy
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Patients with Diabetes Mellitus
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Neuromuscular disease that would interfere with intra-operative recordings
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The Investigator determines that the patient should not be included in the study for reason(s) not already specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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.
Study Documents (Full-Text)
None provided.More Information
Publications
- Bose B, Sestokas AK, Schwartz DM. Neurophysiological monitoring of spinal cord function during instrumented anterior cervical fusion. Spine J. 2004 Mar-Apr;4(2):202-7.
- Chiappa, K.H. (1997) Evoked Potentials in Clinical Medicine
- Deletis, V. (2002), Intraoperative Neurophysiology and Methodologies Used to Monitor the Functional Integrity of the Motor System
- Dykes RW, Terzis JK. Spinal nerve distributions in the upper limb: the organization of the dermatome and afferent myotome. Philos Trans R Soc Lond B Biol Sci. 1981 Aug 12;293(1070):509-54.
- Levin KH, Maggiano HJ, Wilbourn AJ. Cervical radiculopathies: comparison of surgical and EMG localization of single-root lesions. Neurology. 1996 Apr;46(4):1022-5.
- MacDonald DB. Safety of intraoperative transcranial electrical stimulation motor evoked potential monitoring. J Clin Neurophysiol. 2002 Oct;19(5):416-29. Review.
- Møller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7.
- Tsao BE, Levin KH, Bodner RA. Comparison of surgical and electrodiagnostic findings in single root lumbosacral radiculopathies. Muscle Nerve. 2003 Jan;27(1):60-4.
- 2006-039