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
  Purpose

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 Intervention
Failed Back Surgery Syndrome
Other: fMRI and MRS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SCS
patients with Failed back Surgery syndrome treated with SCS
Other: fMRI and MRS
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maarten Moens, MD, Neurosurgery
ClinicalTrials.gov Identifier: NCT01181817     History of Changes
Other Study ID Numbers: vubmtmoensSCS
Study First Received: August 10, 2010
Last Updated: August 17, 2010
Health Authority: belgium: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten

Keywords provided by Universitair Ziekenhuis Brussel:
FBSS
at least one prior spinal surgery

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

ClinicalTrials.gov processed this record on October 20, 2014