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.

Study Overview

• Status: Unknown
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maarten Moens, MD; Phone Number: 0032478884047; Email: mtmoens@gmail.com

Study Locations

• Belgium
  • Brussel, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Maarten Moens, m; Phone Number: 0032478884047; Email: mtmoens@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SCS; patients with Failed back Surgery syndrome treated with SCS	Other: fMRI and MRS; fMRI and MRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional and neurobiological cerebral changes due to SCS	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.	2 years

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: Maarten Moens

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: August 10, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 2010

Study Record Updates

• Last Update Posted (Estimate): August 18, 2010
• Last Update Submitted That Met QC Criteria: August 17, 2010
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: FBSS; at least one prior spinal surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Back Pain; Syndrome; Failed Back Surgery Syndrome
• Other Study ID Numbers: vubmtmoensSCS