NCT02751216

EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Moens Maarten · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is an interventional, observatory single center trial investigating the functional connectivity of the electrical brain activity in high frequency/high density spinal cord stimulation in failed back surgery syndrome patients with back and leg pain.

Detailed description

Based on the reimbursement rules in Belgium, a trial implantation of 4 weeks is necessary before implanting the definitive neurostimulator. The definitive neurostimulator will be implanted minimum 4 weeks after the trial implantation, when the patient reports more than 50% pain reduction and/or more than 50% reduction in pain medication. Patients who are included in this study will have four extra study visits at the University Hospital Brussels. The first assessment will take place during the week prior to surgery, the second minimal one month after definitive implantation of the stimulator. The assessments consist of filling in the Pittsburgh Sleep Quality Index (PSQI) and the Pain Catastrophizing Scale (PCS) and recording brain activity before and during the pain protocol. Additionally, patients will wear an Actiwatch for measuring sleep patterns and fill in a VAS diary (back and leg pain separately), one month before the baseline assessment and one month before the second assessment.

Conditions

• Failed Back Surgery Syndrome

Interventions

Type	Name	Description
OTHER	EEG recording + pain protocol

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2016-04-26
• Last updated: 2019-10-14

Locations

1 site across 1 country: Belgium