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

NCT03626428 | Completed

• 1 other identifier: CRIME
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EEG; fMRI; correlation clinical data; effective connectivity

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Moens Maarten: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

BE (1)