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

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.

Study Overview

• Status: Completed
• Conditions: Failed Back Surgery Syndrome

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Failed Back Surgery Syndrome, treated with spinal cord stimulation.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation pain intensity scores with estimates of effective connectivity	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.	The change between baseline and 3 months after the definitive implantation of the neurostimulator

Collaborators and Investigators

• Sponsor: Moens Maarten

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: fMRI; EEG; effective connectivity; correlation clinical data
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: CRIME

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No