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Spinal Cord Stimulation and Functional MRI

This study is currently recruiting participants.
Verified May 2013 by Ohio State University
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01512121
First received: January 11, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

The overall objective of this study is to assess patterns of fMRI cortical activation with spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define cortical correlates, as well as to investigate cortical representations of pain and pain relief and the interactions therein, in the setting of neuropathic leg pain and SCS.


Condition
Complex Regional Pain Syndrome (CRPS)
Neuropathic Leg Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Investigating the Cortical Correlates of Spinal Cord Stimulation Using Functional Magnetic Resonance Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Effects of spinal cord stimulation on patients with neuropathic leg pain through fMRI analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We are analyzing the data from fMRI scans to understand more the functional activation of the cerebral cortex


Estimated Enrollment: 10
Study Start Date: September 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
functional MRI testing
fMRI scanning with SCS "on" and "off" at different settings.

Detailed Description:

The main objective is to define, using functional magnetic resonance imaging, the effects of spinal cord stimulation (SCS) on cortical and subcortical BOLD effects in patients with neuropathic leg pain. Our hypothesis is that SCS will demonstrate a consistent pattern of BOLD activation that will correlate with symptomatic improvement.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with implanted spinal cord stimulators

Criteria

Inclusion Criteria:

  • Age 18-55 years at time of enrollment.
  • Have previous implantation of thoracic epidural Medtronic Restore Ultra, Prime Advanced and Restore Advanced SCS in place for the treatment of CPRS-type 1 or chronic refractory neuropathic leg pain following FBSS. The implantation must be 3 or more months prior to enrollment.
  • Patient must have reported significant pain improvement (>50%) following implantation of the SCS.
  • Have consistently reproducible pain relief (> 50%) within 10 minutes of switching SCS from an OFF state to an ON state (with "optimal" parameters - see below).
  • The SCS battery is implanted in the buttocks region.
  • Unilateral or bilateral extremity pain.
  • Able to provide informed consent.

Exclusion Criteria:

- Contraindication to MRI such as: SCS lead in the cervical epidural region Cardiac pacemaker Intracranial aneurysm clips, metallic implants or external clips within 10mm of the head Metallic foreign metals within the orbits Pregnancy; (urine pregnancy test will be done to confirm) Claustrophobia

  • Pattern of response to spinal cord stimulation Inconsistent response of pain to spinal cord stimulation Long interval (> 10 minutes) before pain relief following switching SCS from an OFF state to an ON state (with "optimal" parameters) - long "washout" period Lack of significant pain improvement (< 50%) following implantation of SCS
  • Positive history of significant brain lesions or pathology including:
  • Prior ablative neurosurgery
  • History of large vessel strokes or brain tumors
  • Psychological Screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512121

Contacts
Contact: Phuong Nguyen 614-366-6952 phuong.nguyen2@osumc.edu

Locations
United States, Ohio
The Ohio State Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Phuong Nguyen     614-366-6952     phuong.nguyen2@osumc.edu    
Principal Investigator: Ali Rezai, MD            
Sponsors and Collaborators
Ali Rezai, MD
Medtronic
Investigators
Principal Investigator: Ali Rezai, MD Ohio State University
  More Information

No publications provided

Responsible Party: Ali Rezai, MD, Professor of Neurological Surgery, The Ohio State University
ClinicalTrials.gov Identifier: NCT01512121     History of Changes
Other Study ID Numbers: 2011H0040
Study First Received: January 11, 2012
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on May 23, 2013