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Spinal Cord Stimulation and Functional MRI

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ClinicalTrials.gov Identifier: NCT01512121
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Vibhor Krishna, Ohio State University

Study Description
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Brief Summary:
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 or disease
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 Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Investigating the Cortical Correlates of Spinal Cord Stimulation Using Functional Magnetic Resonance Imaging
Actual Study Start Date : September 2011
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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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
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512121


Locations
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United States, Ohio
The Ohio State Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Vibhor Krishna
Medtronic
Investigators
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Principal Investigator: Vibhor Krishna, MD Ohio State University
More Information
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Responsible Party: Vibhor Krishna, Assistant Professor of Neurological Surgery, Ohio State University
ClinicalTrials.gov Identifier: NCT01512121     History of Changes
Other Study ID Numbers: 2011H0040
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
 Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases