Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing

Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain. Clinical Trial

— SCEPTISM  

Official title:

Spinal Cord Evoked Potentials in Candidates for Dorsal Column Stimulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01208805
• Other study ID #: S52573
• Status: Not yet recruiting
• Phase: N/A
• First received: September 23, 2010
• Last updated: September 23, 2010
• Start date: November 2010
• Est. completion date: July 2012

Study information

• Verified date: September 2010
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Tom Theys, MD
• Phone: +32 16 344290
• Email: tom.theys[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Clinical trial committee UZ Leuven
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Intractable
• Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.

Intervention

Behavioral:
• Recording spinal cord evoked potentials
Recording spinal cord evoked potentials from patients suffering from intractable pain in whom epidural electrodes have already been implanted

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium,