Failed Back Surgery SyndromeCRIMENCT03626428
Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study
An observational study of Failed Back Surgery Syndrome, run by Moens Maarten at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2016to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Failed Back Surgery Syndrome, treated with spinal cord stimulation.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- EEG, fMRI, correlation clinical data, effective connectivity
- Medical subject headings
- Failed Back Surgery Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The change between baseline and 3 months after the definitive implantation of the neurostimulator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study startMar 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626428
- Sponsor's protocol ID
- CRIME
- Acronym
- CRIME
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study
- ClinicalTrials.gov ID
- NCT03626428
- Acronym / sponsor ID
- CRIME / CRIME
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- EEG, fMRI, correlation clinical data, effective connectivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Failed Back Surgery Syndrome, treated with spinal cord stimulation.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failed Back Surgery Syndrome, run by Moens Maarten at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.