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Evaluation of the Brain Activity During Spinal Cord Stimulation in Failed Back Surgery Syndrome Using Functional MRI and MRS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01181817
Recruitment Status : Unknown
Verified September 2008 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : August 13, 2010
Last Update Posted : August 18, 2010
Maarten Moens
Information provided by:
Universitair Ziekenhuis Brussel

Brief 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.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Other: fMRI and MRS Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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)
Study Start Date : September 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
patients with Failed back Surgery syndrome treated with SCS
Other: fMRI and MRS
fMRI and MRS

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age male/female patient ≥ 18 years
  2. Patient diagnosed with Failed Back Surgery Syndrome with at least one prior spinal surgery
  3. Patient with low back pain and/or pain in at least one leg
  4. Pain intensity at baseline assessed by VAS > 5 (50%)
  5. Patient willing to provide informed consent.

Exclusion Criteria:

  1. Use of spinal cord stimulation in this patient in the past.
  2. Presence of other clinically significant or disabling chronic pain condition
  3. Expected inability of patients to receive or properly operate the spinal cord stimulation system
  4. History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
  5. Active malignancy
  6. Current use of medication affecting coagulation which cannot be temporarily stopped
  7. 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
  8. Life expectancy of less than 1 year
  9. Existing or planned pregnancy
  10. Existing extreme fear for entering MRI

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 identifier (NCT number): NCT01181817

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Contact: Maarten Moens, MD 0032478884047

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UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Maarten Moens, m    0032478884047   
Principal Investigator: Maarten Moens, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Maarten Moens
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Responsible Party: Maarten Moens, MD, Neurosurgery Identifier: NCT01181817    
Other Study ID Numbers: vubmtmoensSCS
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: August 18, 2010
Last Verified: September 2008
Keywords provided by Universitair Ziekenhuis Brussel:
at least one prior spinal surgery
Additional relevant MeSH terms:
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Failed Back Surgery Syndrome
Pathologic Processes
Postoperative Complications
Back Pain
Neurologic Manifestations