Spinal Cord Evoked Potentials as a Tool to Investigate Se... | NCT01208805

Studies
Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing

NCT01208805

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Sep 24, 2010Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.

Interventions

Recording spinal cord evoked potentials

Countries

Belgium

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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Sep 23, 2010

First Submission Date that Met QC Criteria

Sep 23, 2010

First Posted Date

Sep 24, 2010Estimated

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

Sep 23, 2010

Last Update Posted Date

Sep 24, 2010Estimated

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 study first aim is to investigate the relationship between different patterns of electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to optimize spinal cord stimulation parameters . The second aim of the study is to investigate the role of the spinal cord in some aspects of cognitive-sensory-motor processing, specifically the presence of top-down attentional effects on the sensory analysis of an external stimulus at the spinal cord level.

The study will be performed on patients that will be implanted with a spinal epidural electrode because of chronic intractable pain. From these electrodes, spinal cord evoked potentials (SCEPs) will be recorded.

Detailed Description

Not provided

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Candidates for dorsal column stimulation			Behavioral: Recording spinal cord evoked potentials

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recording spinal cord evoked potentials	Behavioral	Recording spinal cord evoked potentials from patients suffering from intractable pain in whom epidural electrodes have already been implanted

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 18 - 70
Candidates for spinal cord stimulation
Epidural electrode at the the level of the cervical or thoracic spine.

Exclusion Criteria:

Generalized sensory deficit interfering with the recording of spinal cord evoked potentials

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with epidural elektrodes for intractable pain (spinal cord stimulation)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tom Theys, MD	Contact	+32 16 344290		tom.theys@uzleuven.be
Bart Nuttin, MD PhD	Contact	+32 16 344290		bart.nuttin@uzleuven.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven	Brabant	3000	Belgium