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

NCT01181817 | Unknown DMC

• 1 other identifier: vubmtmoensSCS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Failed Back Surgery Syndrome

Keywords

FBSS; at least one prior spinal surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SCS

OTHER

patients with Failed back Surgery syndrome treated with SCS

Other: fMRI and MRS

Interventions

fMRI and MRS OTHER

fMRI and MRS

SCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age male/female patient ≥ 18 years
• Patient diagnosed with Failed Back Surgery Syndrome with at least one prior spinal surgery
• Patient with low back pain and/or pain in at least one leg
• Pain intensity at baseline assessed by VAS \> 5 (50%)
• Patient willing to provide informed consent.

You may not qualify if:

• Use of spinal cord stimulation in this patient in the past.
• Presence of other clinically significant or disabling chronic pain condition
• Expected inability of patients to receive or properly operate the spinal cord stimulation system
• History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
• Active malignancy
• Current use of medication affecting coagulation which cannot be temporarily stopped
• 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
• Life expectancy of less than 1 year
• Existing or planned pregnancy
• Existing extreme fear for entering MRI

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Maarten Moens: collaborator

Study Sites (1)

UZ Brussel

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Maarten Moens, MD

CONTACT

0032478884047; mtmoens@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 13, 2010
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2011
• Last Updated: August 18, 2010

Record last verified: 2008-09

Locations

BE (1)