Spinal Cord Stimulation and Functional MRI
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
First received: January 11, 2012
Last updated: April 2, 2015
Last verified: April 2015
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.
Complex Regional Pain Syndrome (CRPS)
Neuropathic Leg Pain
||Time Perspective: Prospective
||Investigating the Cortical Correlates of Spinal Cord Stimulation Using Functional Magnetic Resonance Imaging
Primary Outcome Measures:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
functional MRI testing
fMRI scanning with SCS "on" and "off" at different settings.
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.
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with implanted spinal cord stimulators
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512121
|The Ohio State Medical Center
|Columbus, Ohio, United States, 43210 |
Ali Rezai, MD
||Ali Rezai, MD
||Ohio State University
No publications provided
||Ali Rezai, MD, Professor of Neurological Surgery, The Ohio State University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 11, 2012
||April 2, 2015
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 09, 2015
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases