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Failed Back Surgery SyndromeSCRATCHYNCT02650349

StruCtuRal And FuncTional Brain Alterations by Conventional Spinal Cord Stimulation And High DensitY Stimulation

A study testing fMRI in people with Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is an interventional prospective observatory single center trial, investigating the supraspinal effects of long term conventional SCS (60 Hz) and paresthesia-free high density SCS in failed back surgery syndrome (FBSS) patients with back and leg pain completed with resting state functional magnetic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Failed Back Surgery Syndrome
What is being tested?
fMRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteBelgium
Study dates
Jan 2016to Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is at least 18 years old.
  • Subject is able and willing to comply with the follow-up schedule and protocol
  • Diagnosis of FBSS with predominant leg pain (VAS) > 5) and non-dominant back pain.
  • Cognitive and language functioning enabling coherent communication between the examiner and the subject;
  • Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy
  • Stable neurologic function in the past 30 days
Show all 9Show fewer
  • In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
  • Subject is able to provide written informed consent
  • Subject speaks Dutch or French.

Who cannot join

  • Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
  • Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
  • Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator, deep brain stimulator or intrathecal drug pump
  • Subject is unable to operate the device or has no relative available.
  • Subjects with indwelling devices that may pose an increased risk of infection
  • Subject currently has an active infection
Show all 15Show fewer
  • Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
  • Subject has participated in another clinical investigation within 30 days
  • Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
  • Subject has been diagnosed with cancer in the past 2 years
  • Life expectancy < 6 months
  • Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
  • Existing extreme fear for entering MRI
  • General contraindication for MRI (pacemaker, etc…)
  • Age male/female patient <18 years

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Brussel

    Brussels, Vlaams Brabant, 1090

Other trials in Belgium

About this study

Official title: StruCtuRal And FuncTional Brain Alterations by Conventional Spinal Cord Stimulation And High DensitY Stimulation: a Combined Voxel-based Morphometry and Resting State Functional Connectivity Study

This study is an interventional prospective observatory single center trial, investigating the supraspinal effects of long term conventional SCS (60 Hz) and paresthesia-free high density SCS in failed back surgery syndrome (FBSS) patients with back and leg pain completed with resting state functional magnetic resonance (rs fMRI) and voxel-based magnetic resonance morphometry (VBM).

Read the detailed description

When patient meets all inclusion criteria and no exclusion criteria, a neuroimaging protocol will be obtained at baseline, prior to trial implantation of SCS. At trial implantation a Vectris® SureScan® MRI 1x8 lead will be implanted, targeted by intraoperative mapping. This lead will be connected to a temporary extension cable and ENS.

Normal trial period will be respected based on the reimbursement rules in Belgium (4 weeks). When the patient is eligible for implantation of the definitive SCS system (more than 50% pain reduction and/or more than 50% reduction in pain medication), patient will undergo surgery for definitive implantation. Then the Vectris® SureScan® MRI lead will be connected to a RestoreSensor® SureScan® MRI neurostimulator.

After stabilisation of the stimulation parameters at least for more than 1 month, the second session of neuroimaging will occur (T1) with the RestoreSensor® SureScan® MRI neurostimulator in MRI mode. Minimal one month later ( 2 months after implantation of definitive SCS system) the patient will undergo the last session of neuroimaging (T2) with the stimulator in MRI mode. During that period prior to the MR-session, a new protocol will occur with paresthesia free high density SCS. The MRI protocol will occur after stabilisation of the stimulation parameters at least for more than 1 month. During the whole period, patients will fill in a VAS diary (back and leg pain separately) and at time of neuroimaging T1 and T2 a Likert-scale in order to evaluate the satisfaction grade of the patient. Additionally, patients will also wear during the whole period an Actiwatch, measuring sleep patterns and filling in questionnaires at B, T1 and T2 (Pittsburgh Sleep Quality Index (PSQI) and Holland Sleep Disorders Questionnaire (HSDQ).

Being tested
fMRI
Keywords
spinal cord stimulation, resting state functional magnetic resonance, voxel-based magnetic resonance morphometry
Medical subject headings
Failed Back Surgery Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fMRIOther

Study groups in NCT02650349
Study groupRoleWhat they receive
spinal cord stimulationExperimentalThe Vectris® SureScan® MRI lead will be connected to a RestoreSensor® SureScan® MRI neurostimulator.
Receives: Other: fMRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grey Mater Volume assessed by Voxel-based morphometry analysis (based on MRI images)

    Measured: The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

  2. Functional connectivity analysis using in-house developed software (based on MRI images)

    Measured: The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

Secondary outcomes (5)

  1. Visual Analogue Scale (VAS) pain diary

    Measured: Three times every day (morning, afternoon and evening), starting 1 week before baseline measurements up to 2 months until study completion.

  2. Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).

    Measured: The difference between 7 days at baseline before implantation and 7 days before T1 ( 1 month after definitive implantation) and 7 days before T2 ( 2 months after definitive implantation).

  3. Subjective sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)

    Measured: The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

  4. Pain catastrophizing is assessed by the Pain Catastrophizing Scale (PCS)

    Measured: The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

  5. Likert-scale in order to evaluate the satisfaction grade of the patient.

    Measured: The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02650349
Sponsor's protocol ID
SCRATCHY1
Acronym
SCRATCHY
Status last verified
Apr 2019
First submitted
24 Dec 2015
Last updated
18 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • Rasche D, Siebert S, Stippich C, Kress B, Nennig E, Sartor K, Tronnier VM. [Spinal cord stimulation in Failed-Back-Surgery-Syndrome. Preliminary study for the evaluation of therapy by functional magnetic resonance imaging (fMRI)]. Schmerz. 2005 Nov;19(6):497-500, 502-5. doi: 10.1007/s00482-005-0388-9. German.

    PubMed 15770488

  • Stancak A, Kozak J, Vrba I, Tintera J, Vrana J, Polacek H, Stancak M. Functional magnetic resonance imaging of cerebral activation during spinal cord stimulation in failed back surgery syndrome patients. Eur J Pain. 2008 Feb;12(2):137-48. doi: 10.1016/j.ejpain.2007.03.003. Epub 2007 Oct 30.

    PubMed 17977762

  • Moens M, Sunaert S, Marien P, Brouns R, De Smedt A, Droogmans S, Van Schuerbeek P, Peeters R, Poelaert J, Nuttin B. Spinal cord stimulation modulates cerebral function: an fMRI study. Neuroradiology. 2012 Dec;54(12):1399-407. doi: 10.1007/s00234-012-1087-8. Epub 2012 Sep 2.

    PubMed 22941431

  • Moens M, Droogmans S, Spapen H, De Smedt A, Brouns R, Van Schuerbeek P, Luypaert R, Poelaert J, Nuttin B. Feasibility of cerebral magnetic resonance imaging in patients with externalised spinal cord stimulator. Clin Neurol Neurosurg. 2012 Feb;114(2):135-41. doi: 10.1016/j.clineuro.2011.09.013. Epub 2011 Oct 22.

    PubMed 22018720

  • Moens M, Marien P, Brouns R, Poelaert J, De Smedt A, Buyl R, Droogmans S, Van Schuerbeek P, Sunaert S, Nuttin B. Spinal cord stimulation modulates cerebral neurobiology: a proton magnetic resonance spectroscopy study. Neuroradiology. 2013 Aug;55(8):1039-1047. doi: 10.1007/s00234-013-1200-7. Epub 2013 May 12.

    PubMed 23665999

  • Qiu Y, Lv X, Su H, Jiang G, Li C, Tian J. Structural and functional brain alterations in end stage renal disease patients on routine hemodialysis: a voxel-based morphometry and resting state functional connectivity study. PLoS One. 2014 May 22;9(5):e98346. doi: 10.1371/journal.pone.0098346. eCollection 2014.

    PubMed 24854737

  • Chen Q, Yang W, Li W, Wei D, Li H, Lei Q, Zhang Q, Qiu J. Association of creative achievement with cognitive flexibility by a combined voxel-based morphometry and resting-state functional connectivity study. Neuroimage. 2014 Nov 15;102 Pt 2:474-83. doi: 10.1016/j.neuroimage.2014.08.008. Epub 2014 Aug 12.

    PubMed 25123973

  • Lui S, Deng W, Huang X, Jiang L, Ma X, Chen H, Zhang T, Li X, Li D, Zou L, Tang H, Zhou XJ, Mechelli A, Collier DA, Sweeney JA, Li T, Gong Q. Association of cerebral deficits with clinical symptoms in antipsychotic-naive first-episode schizophrenia: an optimized voxel-based morphometry and resting state functional connectivity study. Am J Psychiatry. 2009 Feb;166(2):196-205. doi: 10.1176/appi.ajp.2008.08020183. Epub 2008 Nov 3.

    PubMed 18981063

  • Becerra L, Sava S, Simons LE, Drosos AM, Sethna N, Berde C, Lebel AA, Borsook D. Intrinsic brain networks normalize with treatment in pediatric complex regional pain syndrome. Neuroimage Clin. 2014 Aug 10;6:347-69. doi: 10.1016/j.nicl.2014.07.012. eCollection 2014.

    PubMed 25379449

  • Yu R, Gollub RL, Spaeth R, Napadow V, Wasan A, Kong J. Disrupted functional connectivity of the periaqueductal gray in chronic low back pain. Neuroimage Clin. 2014 Aug 23;6:100-8. doi: 10.1016/j.nicl.2014.08.019. eCollection 2014.

    PubMed 25379421

Questions about this trial

What is this clinical trial studying?

A study testing fMRI in people with Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grey Mater Volume assessed by Voxel-based morphometry analysis (based on MRI images) (time frame: The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02650349, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.

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