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

Failed Back Surgery Syndrome Clinical Trial

— CRIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626428
• Other study ID #: CRIME
• Status: Completed
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: August 2018
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Moens Maarten

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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