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

NCT ID: NCT00696501

Last Updated: 2017-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Spine Surgery Neuromuscular Mapping Neurodiagnostics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lahey Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Subu N. Magge, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic, Inc.

Locations

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Neurosurgery Department, Lahey Clinic, Inc.

Burlington, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 8780083 (View on PubMed)

Moller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7. No abstract available.

Reference Type BACKGROUND
PMID: 8579167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15016399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12477987 (View on PubMed)

Deletis, V. (2002), Intraoperative Neurophysiology and Methodologies Used to Monitor the Functional Integrity of the Motor System

Reference Type BACKGROUND

Chiappa, K.H. (1997) Evoked Potentials in Clinical Medicine

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 6115429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12508296 (View on PubMed)

Other Identifiers

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2006-039

Identifier Type: -

Identifier Source: org_study_id

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