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

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.

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is at least 18 years old.
Diagnosis of FBSS with predominant leg pain (VAS) > 5) and non-dominant back pain.
Cognitive and language functioning enabling coherent communication between the examiner and the subject;
Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy
Stable neurologic function in the past 30 days
Subject is included in the previous studies and both EEG and fMRI data are available.

Exclusion criteria

Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
Subjects currently has an active infection

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Moens Maarten

Other

Registry information

Acronym: CRIME

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Aug 13, 2018
Registry last updated: Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed