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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Universitair Ziekenhuis Brussel.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Maarten Moens
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01181817
First received: August 10, 2010
Last updated: August 17, 2010
Last verified: September 2008

August 10, 2010
August 17, 2010
September 2008
September 2010   (final data collection date for primary outcome measure)
functional and neurobiological cerebral changes due to SCS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
functional and neurobiological cerebral changes due to SCS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01181817 on ClinicalTrials.gov Archive Site
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Not Provided
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Evaluation of the Brain Activity During Spinal Cord Stimulation in Failed Back Surgery Syndrome Using Functional MRI and MRS
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.

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)

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Failed Back Surgery Syndrome
Other: fMRI and MRS
fMRI and MRS
SCS
patients with Failed back Surgery syndrome treated with SCS
Intervention: Other: fMRI and MRS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2011
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Maarten Moens, MD 0032478884047 mtmoens@gmail.com
Belgium
 
NCT01181817
vubmtmoensSCS
Yes
Maarten Moens, MD, Neurosurgery
Universitair Ziekenhuis Brussel
Maarten Moens
Not Provided
Universitair Ziekenhuis Brussel
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP