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

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ClinicalTrials.gov Identifier: NCT03626428
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Moens Maarten, Universitair Ziekenhuis Brussel

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.


Condition or disease
Failed Back Surgery Syndrome

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Failed Back Surgery Syndrome, treated with spinal cord stimulation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626428


Locations
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Belgium
Universitair Ziekenhuis Brussel
Jette, Belgium, 1090
Sponsors and Collaborators
Moens Maarten

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Responsible Party: Moens Maarten, Principal Investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03626428     History of Changes
Other Study ID Numbers: CRIME
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Moens Maarten, Universitair Ziekenhuis Brussel:
EEG
fMRI
correlation clinical data
effective connectivity

Additional relevant MeSH terms:
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Failed Back Surgery Syndrome
Postoperative Complications
Pathologic Processes
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms