STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation

STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation: a Combined Voxel-based Morphometry and Resting State Functional Connectivity Study

This study is an interventional prospective observatory single center trial, investigating the supraspinal effects of long term paresthesia-free high frequency SCS in FBSS patients with back and leg pain completed with resting state functional magnetic resonance (rs fMRI) and voxel-based magnetic resonance morphometry (VBM).

When patient meets all inclusion criteria and no exclusion criteria, a neuroimaging protocol will be obtained at baseline, prior to trial implantation of SCS.

Normal trial period will be respected based on the reimbursement rules in Belgium (4 weeks). When the patient is eligible for implantation of the definitive SCS system (more than 50% pain reduction and/or more than 50% reduction in pain medication), patient will undergo surgery for definitive implantation.

After stabilisation of the stimulation parameters at least for more than 1 month, the second session of neuroimaging will occur (T1). Minimal one month later (2 months after implantation of definitive SCS system) the patient will undergo the last session of neuroimaging (T2). The MRI protocol will occur after stabilisation of the stimulation parameters at least for more than 1 month. During the whole period, patients will fill in a VAS diary and at time of neuroimaging T1 and T2 a Likert-scale in order to evaluate the satisfaction grade of the patient. Additionally, patients will also wear 1 month before neuroimaging an Actiwatch, measuring sleep patterns and filling in questionnaires at baseline, T1 and T2 (Pittsburgh Sleep Quality Index (PSQI).

Inclusion Criteria:

• Subject is at least 18 years old.
• Subject is able and willing to comply with the follow-up schedule and protocol
• Diagnosis of FBSS with predominant back pain (visual analogue scale (VAS) > 5).
• Cognitive and language functioning enabling coherent communication between the examiner and the subject;
• Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy
• Stable neurologic function in the past 30 days
• In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
• Subject is able to provide written informed consent
• Subject speaks Dutch or French.

Exclusion Criteria:

• Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
• Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
• Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator, deep brain stimulator or intrathecal drug pump
• Subject is unable to operate the device or has no relative available.
• Subjects with indwelling devices that may pose an increased risk of infection
• Subject currently has an active infection
• Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
• Subject has participated in another clinical investigation within 30 days
• Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
• Subject has been diagnosed with cancer in the past 2 years
• Life expectancy < 6 months
• Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
• Existing extreme fear for entering MRI
• General contraindication for MRI (pacemaker, etc…)
• Age male/female patient <18 years