Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study (CRIME)
|ClinicalTrials.gov Identifier: NCT03626428|
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 16, 2018
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.
|Condition or disease|
|Failed Back Surgery Syndrome|
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
- Correlation pain intensity scores with estimates of effective connectivity [ Time Frame: The change between baseline and 3 months after the definitive implantation of the neurostimulator ]The investigators will evaluate the degree of correlation between pain intensity ratings and effective connectivity based on fMRI data and between pain intensity ratings and effective connectivity based on EEG data.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626428
|Universitair Ziekenhuis Brussel|
|Jette, Belgium, 1090|