Status:
COMPLETED
Spinal Cord Stimulation and Functional MRI
Lead Sponsor:
Vibhor Krishna
Collaborating Sponsors:
Medtronic
Conditions:
Complex Regional Pain Syndrome (CRPS)
Neuropathic Leg Pain
Eligibility:
All Genders
18-55 years
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,...
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 pai...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01512121
Start Date
September 1 2011
End Date
August 1 2017
Last Update
September 23 2019
Active Locations (1)
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1
The Ohio State Medical Center
Columbus, Ohio, United States, 43210