NCT02650349

StruCtuRal And FuncTional Brain Alterations by Conventional Spinal Cord Stimulation And High DensitY Stimulation

StruCtuRal And FuncTional Brain Alterations by Conventional Spinal Cord Stimulation And High DensitY Stimulation: a Combined Voxel-based Morphometry and Resting State Functional Connectivity Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an interventional prospective observatory single center trial, investigating the supraspinal effects of long term conventional SCS (60 Hz) and paresthesia-free high density SCS in failed back surgery syndrome (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. At trial implantation a Vectris® SureScan® MRI 1x8 lead will be implanted, targeted by intraoperative mapping. This lead will be connected to a temporary extension cable and ENS. 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. Then the Vectris® SureScan® MRI lead will be connected to a RestoreSensor® SureScan® MRI neurostimulator. After stabilisation of the stimulation parameters at least for more than 1 month, the second session of neuroimaging will occur (T1) with the RestoreSensor® SureScan® MRI neurostimulator in MRI mode. Minimal one month later ( 2 months after implantation of definitive SCS system) the patient will undergo the last session of neuroimaging (T2) with the stimulator in MRI mode. During that period prior to the MR-session, a new protocol will occur with paresthesia free high density SCS. 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 (back and leg pain separately) 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 during the whole period an Actiwatch, measuring sleep patterns and filling in questionnaires at B, T1 and T2 (Pittsburgh Sleep Quality Index (PSQI) and Holland Sleep Disorders Questionnaire (HSDQ).

Conditions

• Failed Back Surgery Syndrome

Interventions

Type	Name	Description
OTHER	fMRI

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-01-01
• Completion: 2018-08-01
• First posted: 2016-01-08
• Last updated: 2019-04-18

Locations

1 site across 1 country: Belgium