NCT00696501|Terminated
Study Stopped
One of the investigators left the Institution
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One of the investigators left the Institution
Sponsor study identifier
observational
203
1 country
1
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 10, 2008
Actual (reported)June 12, 2008
Actual (reported)December 2016
Actual (reported)December 2016
Actual (reported)Build a database of spinal nerve root innervation utilizing direct nerve root stimulation
Data collected during surgery and a 30 day post-op visit
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
All neurosurgical patients will be screened for potential eligibility from the Neurosurgery Department's Clinical and operative schedules.
Neurosurgery Department, Lahey Clinic, Inc.
Burlington, Massachusetts, 01805, United States
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.
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.
Subu N. Magge, M.D.
Lahey Clinic, Inc.
203 participants (actual enrollment reported by the registry).
First Submitted
June 10, 2008
First Posted
June 12, 2008
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
SpinePal Open Pilot
Contact the study team to confirm eligibility.
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.
Moller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7. No abstract available.
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.
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.
Deletis, V. (2002), Intraoperative Neurophysiology and Methodologies Used to Monitor the Functional Integrity of the Motor System
Chiappa, K.H. (1997) Evoked Potentials in Clinical Medicine
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
August 24, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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