Spinal Cord Stimulation and Functional MRI

NCT ID: NCT01512121

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2017-08-31

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.

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.

Conditions

Complex Regional Pain Syndrome (CRPS); Neuropathic Leg Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

functional MRI testing

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Vibhor Krishna

OTHER

Sponsor Role: lead

Responsible Party

Vibhor Krishna

Assistant Professor of Neurological Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vibhor Krishna, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2011H0040

Identifier Type: -

Identifier Source: org_study_id