Spinal Cord Stimulation and Functional MRI
Completed
Conditions studied: Complex Regional Pain Syndrome (CRPS), Neuropathic Leg Pain
In brief
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.
Key facts
- Study ID
- NCT01512121
- Run by
- Vibhor Krishna
- People needed
- 10
- Starts
- 2011-09-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2019-09-23
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- The Ohio State Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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