Clinical trial NCT00696501: Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns
Official title: Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spine Surgery
Neuromuscular Mapping
Neurodiagnostics
Keywords: Neuromuscular mapping
Spinal surgery
Neurodiagnostics
Segmental root innervation
Dermatomal innervation
Myotomal innervation
Nerve roots
Sensory
Signs and Symptoms
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neurosurgical patients will be screened for potential eligibility from the Neurosurgery Department's Clinical and operative schedules.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Build a database of spinal nerve root innervation utilizing direct nerve root stimulation
timeFrame: Data collected during surgery and a 30 day post-op visit
Secondary outcomes:
measure: Compare clinical symptoms of the patient to the direct muscle activation via spinal nerve root stimulation
timeFrame: Data collected during surgery and a 30 day post-op visit
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Neurosurgery Department, Lahey Clinic, Inc.
state: Massachusetts
Study officials:
affiliation: Lahey Clinic, Inc.
name: Subu N. Magge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1098/rstb.1981.0083.
citation: 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. doi: 10.1002/mus.10291.
citation: 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. doi: 10.1212/wnl.46.4.1022.
citation: Moller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7. No abstract available.
citation: 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. doi: 10.1016/j.spinee.2003.06.001.
citation: MacDonald DB. Safety of intraoperative transcranial electrical stimulation motor evoked potential monitoring. J Clin Neurophysiol. 2002 Oct;19(5):416-29. doi: 10.1097/00004691-200210000-00005.
citation: Deletis, V. (2002), Intraoperative Neurophysiology and Methodologies Used to Monitor the Functional Integrity of the Motor System
citation: Chiappa, K.H. (1997) Evoked Potentials in Clinical Medicine