Failed Back Surgery Syndrome
Conditions
Keywords
spinal cord stimulation, resting state functional magnetic resonance, voxel-based magnetic resonance morphometry
Brief summary
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).
Detailed description
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).
Interventions
OTHERfMRI
Sponsors
Nevro
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grey Mater Volume assessed by Voxel-based morphometry analysis (based on MRI images) | The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2). |
| Functional connectivity analysis using in-house developed software (based on MRI images) | The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI) | The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2). | — |
| Visual Analogue Scale (VAS) pain diary | Three times every day (morning, afternoon and evening), starting 1 week before baseline measurements up to 2 months until study completion | — |
| Likert-scale in order to evaluate the satisfaction grade of the patient. | The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2). | — |
| Pain catastrophizing is assessed by the Pain Catastrophizing Scale (PCS) | The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2). | — |
| Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics) | The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2). | This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality |
Countries
Belgium
Outcome results
None listed