NCT01181817

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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)

Conditions

• Failed Back Surgery Syndrome

Interventions

Type	Name	Description
OTHER	fMRI and MRS	fMRI and MRS

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-09-01
• Completion: 2011-09-01
• First posted: 2010-08-13
• Last updated: 2010-08-18

Locations

1 site across 1 country: Belgium