NCT02650362

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (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 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).

Conditions

• Failed Back Surgery Syndrome

Interventions

Type	Name	Description
OTHER	fMRI

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-08-01
• Completion: 2018-08-01
• First posted: 2016-01-08
• Last updated: 2019-04-18

Locations

1 site across 1 country: Belgium