Direct Stimulation Of Spinal Nerve Roots To Determine Sen... | NCT00696501

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

NCT00696501

Sponsor

Lahey Clinic

Status

Terminated

Last Update Posted

Aug 24, 2017Actual

Enrollment

203Actual

Phase

Not provided

Conditions

Spine Surgery
Neuromuscular Mapping
Neurodiagnostics

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

One of the investigators left the Institution

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jun 10, 2008

First Submission Date that Met QC Criteria

Jun 10, 2008

First Posted Date

Jun 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2017

Last Update Posted Date

Aug 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

203Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

All neurosurgical patients will be screened for potential eligibility from the Neurosurgery Department's Clinical and operative schedules.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Subu N. Magge, M.D.	Lahey Clinic, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurosurgery Department, Lahey Clinic, Inc.		Burlington	Massachusetts	01805	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
6115429	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.
12508296	Background	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.