Spinal Cord Stimulation and Functional MRI

NCT01512121 | Completed

• 1 other identifier: 2011H0040
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndrome (CRPS); Neuropathic Leg Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

functional MRI testing

fMRI scanning with SCS "on" and "off" at different settings.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with implanted spinal cord stimulators

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Vibhor Krishna: lead
• Medtronic: collaborator

Study Sites (1)

The Ohio State Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Vibhor Krishna, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Neurological Surgery

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 19, 2012
• Study Start: September 1, 2011
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

US (1)