Spinal Cord Stimulation and Functional MRI

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

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.

Study Overview

• Status: Completed
• Conditions: Complex Regional Pain Syndrome (CRPS); Neuropathic Leg Pain

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with implanted spinal cord stimulators

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
functional MRI testing; fMRI scanning with SCS "on" and "off" at different settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of spinal cord stimulation on patients with neuropathic leg pain through fMRI analysis	We are analyzing the data from fMRI scans to understand more the functional activation of the cerebral cortex	1 year

Collaborators and Investigators

• Sponsor: Vibhor Krishna
• Collaborators: Medtronic
• Investigators: Principal Investigator: Vibhor Krishna, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2011
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: January 13, 2012
• First Posted (ESTIMATE): January 19, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: 2011H0040