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

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00696501
• Other study ID #: 2006-039
• Status: Terminated
• Phase: N/A
• First received: June 10, 2008
• Last updated: August 22, 2017
• Start date: May 2006
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 203
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurodiagnostics
• Neuromuscular Mapping
• Spine Surgery

Locations

Country	Name	City	State
United States	Neurosurgery Department, Lahey Clinic, Inc.	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View 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. — View Citation

MacDonald DB. Safety of intraoperative transcranial electrical stimulation motor evoked potential monitoring. J Clin Neurophysiol. 2002 Oct;19(5):416-29. Review. — View Citation

Møller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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