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Spinal Cord Stimulation and Functional MRI

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Vibhor Krishna, The Ohio State University Identifier:
First received: January 11, 2012
Last updated: March 29, 2017
Last verified: March 2017
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.

Complex Regional Pain Syndrome (CRPS)
Neuropathic Leg Pain

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

Resource links provided by NLM:

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 ]
    We are analyzing the data from fMRI scans to understand more the functional activation of the cerebral cortex

Enrollment: 10
Study Start Date: September 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with implanted spinal cord stimulators

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
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Please refer to this study by its identifier: NCT01512121

United States, Ohio
The Ohio State Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Vibhor Krishna
Principal Investigator: Vibhor Krishna, MD Ohio State University
  More Information

Responsible Party: Vibhor Krishna, Assistant Professor of Neurological Surgery, The Ohio State University Identifier: NCT01512121     History of Changes
Other Study ID Numbers: 2011H0040
Study First Received: January 11, 2012
Last Updated: March 29, 2017

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases processed this record on April 25, 2017