NCT03626428

Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Moens Maarten · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, a retrospective analysis will be performed on collected data of 14 patients with Failed Back Surgery Syndrome, treated with Spinal cord stimulation. In separate studies, fMRI and EEG recordings were made in resting state conditions on two time points. The fMRI assessments and EEG recordings were performed before the SCS implantation (baseline) and repeated around 3 months after the definitive SCS implantation. During both assessments, patients were asked to fill in a VAS diary for their leg and back pain (scores from 0 to 10). The aim of the current retrospective study is to correlate the clinical data obtained from the VAS scores, with estimates of effective connectivity (obtained from fMRI and EEG). Effective connectivity will be calculated by using dynamic causal modeling (DCM) on the baseline data and the data obtained 3 months after SCS. The aim is to evaluate whether DCM data of EEG is equally/worse/better correlating with the clinical data as DCM data of fMRI.

Conditions

• Failed Back Surgery Syndrome

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2018-08-13
• Last updated: 2018-08-16

Locations

1 site across 1 country: Belgium