Spinal Cord Stimulation and Functional MRI

Complex Regional Pain Syndrome (CRPS) Clinical Trial

Official title:

Investigating the Cortical Correlates of Spinal Cord Stimulation Using Functional Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512121
• Other study ID #: 2011H0040
• Status: Completed
• Start date: September 2011
• Est. completion date: August 2017

Study information

• Verified date: September 2019
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome (CRPS)
• Complex Regional Pain Syndromes
• Neuropathic Leg Pain
• Reflex Sympathetic Dystrophy

Locations

Country	Name	City	State
United States	The Ohio State Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Vibhor Krishna	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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