Failed Back Surgery SyndromeNCT01181817
Evaluation of the Brain Activity During Spinal Cord Stimulation in Failed Back Surgery Syndrome Using Functional MRI and MRS
A study testing fMRI and MRS in people with Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Functional Magnetic Resonance Imaging (fMRI)and MR Spectroscopy of the brain are perfect tools to investigate the changes in the brainstem and brain evoked by the orthodromically impulses of a SCS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- fMRI and MRS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2008to Sep 2011
- Phase
- Interventional
- 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
Who may be able to join
- Age male/female patient ≥ 18 years
- Patient diagnosed with Failed Back Surgery Syndrome with at least one prior spinal surgery
- Patient with low back pain and/or pain in at least one leg
- Pain intensity at baseline assessed by VAS > 5 (50%)
- Patient willing to provide informed consent.
Who cannot join
- Use of spinal cord stimulation in this patient in the past.
- Presence of other clinically significant or disabling chronic pain condition
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
- Current use of medication affecting coagulation which cannot be temporarily stopped
Show all 10Show fewer
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Life expectancy of less than 1 year
- Existing or planned pregnancy
- Existing extreme fear for entering MRI
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels, Brussels Capital, 1090
Maarten Moens, m, 0032478884047, mtmoens@gmail.com
Maarten Moens, MD
About this study
Official title: Evaluation of the Brain Activity During Spinal Cord Stimulation (SCS) in Failed Back Surgery Syndrome Using Functional Magnetic Resonance Imaging (fMRI) and Magnetic ResonanceSpectroscopy (MRS)
Functional Magnetic Resonance Imaging (fMRI)and MR Spectroscopy of the brain are perfect tools to investigate the changes in the brainstem and brain evoked by the orthodromically impulses of a SCS.
Read the detailed description
In case a patient meets all inclusion and no exclusion criteria, he/she will be implanted with an epidural neurostimulation lead (electrode).
The day of implant will be recorded as day 0 (table 1) and will always be a Thursday.
Post lead implant, the patient will be hospitalized for a small week as per common practice in case of the intervention outside of the study.
During hospital stay, the investigator of the study, or a representative of the product manufacturer, Medtronic®, will search for the optimal stimulation parameters to evoke correct paraesthesia coverage and pain relief. If appropriate parameters have been found, these will be saved in the external neurostimulator.
After maximum one hour, the neurostimulator will be turned off again.
On day 12, a Tuesday, a MR spectrospoy will be performed. Each patient will undergo three sessions.
Each session will be divided into a MR spectroscopy session and fMRI session without stimulation and a session with stimulation. The MR spectroscopy session without stimulation will bring us the baseline in neurobiology of neuropathic pain; after measurement, the stimulator will be switch on and a MR spectroscopy will be performed during a longer period of time (10 min) in order to determine neurobiological changes in time during SCS.
The 3 MR spectroscopy sessions will be performed on different regions in the brain (both talami and rostral region of anterior cingulated cortex)
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- fMRI and MRS
- Keywords
- FBSS, at least one prior spinal surgery
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI and MRSOther
fMRI and MRS
| Study group | Role | What they receive |
|---|---|---|
| SCS | Other | patients with Failed back Surgery syndrome treated with SCS Receives: Other: fMRI and MRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional and neurobiological cerebral changes due to SCS
To compare brain activity before and after spinal cord stimulation (with appropriate paraesthesia) using functional magnetic resonance imaging and neurobiological changes in the spectrum (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) due to stimulation measured by MRS. The primary outcome is the difference in neurobiology between baseline and when the stimulator is on.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2010 (estimated)
- Study completionSep 2011 (estimated)
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.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Maarten Moens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181817
- Sponsor's protocol ID
- vubmtmoensSCS
- Status last verified
- Sep 2008
- First submitted
- 10 Aug 2010
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Brain Activity During Spinal Cord Stimulation (SCS) in Failed Back Surgery Syndrome Using Functional Magnetic Resonance Imaging (fMRI) and Magnetic ResonanceSpectroscopy (MRS)
- ClinicalTrials.gov ID
- NCT01181817
- Acronym / sponsor ID
- vubmtmoensSCS
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- FBSS, at least one prior spinal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Maarten Moens
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 13 Aug 2010 (estimated)
- 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.
Functional Magnetic Resonance Imaging (fMRI)and MR Spectroscopy of the brain are perfect tools to investigate the changes in the brainstem and brain evoked by the orthodromically impulses of a SCS.
Detailed description
In case a patient meets all inclusion and no exclusion criteria, he/she will be implanted with an epidural neurostimulation lead (electrode).
The day of implant will be recorded as day 0 (table 1) and will always be a Thursday.
Post lead implant, the patient will be hospitalized for a small week as per common practice in case of the intervention outside of the study.
During hospital stay, the investigator of the study, or a representative of the product manufacturer, Medtronic®, will search for the optimal stimulation parameters to evoke correct paraesthesia coverage and pain relief. If appropriate parameters have been found, these will be saved in the external neurostimulator.
After maximum one hour, the neurostimulator will be turned off again.
On day 12, a Tuesday, a MR spectrospoy will be performed. Each patient will undergo three sessions.
Each session will be divided into a MR spectroscopy session and fMRI session without stimulation and a session with stimulation. The MR spectroscopy session without stimulation will bring us the baseline in neurobiology of neuropathic pain; after measurement, the stimulator will be switch on and a MR spectroscopy will be performed during a longer period of time (10 min) in order to determine neurobiological changes in time during SCS.
The 3 MR spectroscopy sessions will be performed on different regions in the brain (both talami and rostral region of anterior cingulated cortex)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCS | Other | Other: fMRI and MRSpatients with Failed back Surgery syndrome treated with SCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age male/female patient ≥ 18 years
- Patient diagnosed with Failed Back Surgery Syndrome with at least one prior spinal surgery
- Patient with low back pain and/or pain in at least one leg
- Pain intensity at baseline assessed by VAS > 5 (50%)
- Patient willing to provide informed consent.
Key exclusion criteria (10 listed)
- Use of spinal cord stimulation in this patient in the past.
- Presence of other clinically significant or disabling chronic pain condition
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI and MRSfMRI and MRS | Other | SCS |
Primary outcome
functional and neurobiological cerebral changes due to SCS
Time frame: 2 years
To compare brain activity before and after spinal cord stimulation (with appropriate paraesthesia) using functional magnetic resonance imaging and neurobiological changes in the spectrum (gamma-aminobutyric acid (GABA) glutamate (Glu) glutamine (Gln) N-acetylaspartate (NAA) Choline-containing compounds (Cho) Creatine plus phophocreatine (total creatine: Cr) Myo-inositiol (Ins) Choline (Cho) Glucose (Glc) Lactate (Lac)) due to stimulation measured by MRS. The primary outcome is the difference in neurobiology between baseline and when the stimulator is on.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI and MRS in people with Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Aug 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Moens, MD (0032478884047, mtmoens@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional and neurobiological cerebral changes due to SCS (time frame: 2 years). 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 18 Aug 2010.