Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing (SCEPTISM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01208805
First received: September 23, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.
Behavioral: Recording spinal cord evoked potentials

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spinal Cord Evoked Potentials in Candidates for Dorsal Column Stimulation

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Candidates for dorsal column stimulation 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208805

Contacts
Contact: Tom Theys, MD +32 16 344290 tom.theys@uzleuven.be
Contact: Bart Nuttin, MD PhD +32 16 344290 bart.nuttin@uzleuven.be

Locations
Belgium
UZ Leuven Not yet recruiting
Leuven, Brabant, Belgium, 3000
Contact: An Hendriks    +32 16 34 19 98    an.hendriks@uzleuven.be   
Principal Investigator: Bart Nuttin, MD PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Prof Bart Nuttin, UZ Leuven
ClinicalTrials.gov Identifier: NCT01208805     History of Changes
Other Study ID Numbers: S52573
Study First Received: September 23, 2010
Last Updated: September 23, 2010
Health Authority: Belgium: Clinical trial committee UZ Leuven

Additional relevant MeSH terms:
Pain, Intractable
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014