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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by:

Study Description
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
Failed Back Surgery Syndrome Other: fMRI and MRS

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

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
Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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): NCT01181817


Contacts
Contact: Maarten Moens, MD 0032478884047 mtmoens@gmail.com

Locations
Belgium
UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Maarten Moens, m    0032478884047    mtmoens@gmail.com   
Principal Investigator: Maarten Moens, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Maarten Moens
More Information

Responsible Party: Maarten Moens, MD, Neurosurgery
ClinicalTrials.gov Identifier: NCT01181817     History of Changes
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:
FBSS
at least one prior spinal surgery

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