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.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Failed Back Surgery Syndrome||Other: fMRI and MRS||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
patients with Failed back Surgery syndrome treated with SCS
Other: fMRI and MRS
fMRI and MRS
- 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.
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
|Contact: Maarten Moens, MDemail@example.com|
|Brussel, Belgium, 1090|
|Contact: Maarten Moens, m 0032478884047 firstname.lastname@example.org|
|Principal Investigator: Maarten Moens, MD|