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OpenTrials
Completed

NCT Number: NCT01512121

Spinal Cord Stimulation and Functional MRI

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Vibhor Krishna

Other

Collaborators

  • Medtronic

Registry information

Official study title

Investigating the Cortical Correlates of Spinal Cord Stimulation Using Functional Magnetic Resonance Imaging

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2012
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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