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Failed Back Surgery SyndromeEEGInspirationNCT02751216

EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome

A study testing EEG recording + pain protocol in people with Failed Back Surgery Syndrome, run by Moens Maarten 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, observatory single center trial investigating the functional connectivity of the electrical brain activity in high frequency/high density spinal cord stimulation in failed back surgery syndrome patients with back and leg pain. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Failed Back Surgery Syndrome
What is being tested?
EEG recording + pain protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBelgium
Study dates
May 2016to Jan 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 to 65 years
  • 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
  • Subjects 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

This study is an interventional, observatory single center trial investigating the functional connectivity of the electrical brain activity in high frequency/high density spinal cord stimulation in failed back surgery syndrome patients with back and leg pain.

Read the detailed description

Based on the reimbursement rules in Belgium, a trial implantation of 4 weeks is necessary before implanting the definitive neurostimulator. The definitive neurostimulator will be implanted minimum 4 weeks after the trial implantation, when the patient reports more than 50% pain reduction and/or more than 50% reduction in pain medication.

Patients who are included in this study will have four extra study visits at the University Hospital Brussels. The first assessment will take place during the week prior to surgery, the second minimal one month after definitive implantation of the stimulator. The assessments consist of filling in the Pittsburgh Sleep Quality Index (PSQI) and the Pain Catastrophizing Scale (PCS) and recording brain activity before and during the pain protocol. Additionally, patients will wear an Actiwatch for measuring sleep patterns and fill in a VAS diary (back and leg pain separately), one month before the baseline assessment and one month before the second assessment.

Being tested
EEG recording + pain protocol
Keywords
high frequency / high density spinal cord stimulation, EEG, conditioned pain modulation
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.

  • EEG recording + pain protocolOther

Study groups in NCT02751216
Study groupRoleWhat they receive
spinal cord stimulationExperimentalNot described
Receives: Other: EEG recording + pain protocol

What is being measured

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

  1. Functional connectivity

    EEG recordings to measure functional connectivity in the brain

    Measured: The change between baseline and 1 month after definitive implantation of the neurostimulator

Secondary outcomes (5)

  1. Functioning of the descending inhibitory pathway

    Functioning of the descending pathway will be measured with the conditioned pain modulation paradigm by using electrical stimulation and cold water

    Measured: The change between baseline and 1 month after definitive implantation of the neurostimulator

  2. Visual Analogue Scale (VAS) pain diary

    Measured: Three times every day (morning, afternoon and evening), starting 1 month before baseline measurements up to the second measurement 1 month after definitive implantation of the neurostimulator (at study completion).

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

    This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality

    Measured: The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation).

  4. Pain Catastrophizing

    Pain catastrophizing is assess be using the 'pain catastrophizing scale'.

    Measured: The change between baseline and 1 month after definitive implantation of the neurostimulator

  5. Subjective sleep quality

    Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).

    Measured: The change between baseline and 1 month after definitive implantation of the neurostimulator

Timeline

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

  1. First posted26 Apr 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2017
  4. Study completionJan 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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02751216
Sponsor's protocol ID
EEGInspiration1
Acronym
EEGInspiration
Status last verified
Oct 2019
First submitted
18 Apr 2016
Last updated
14 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • De Ridder D, Vanneste S. Burst and Tonic Spinal Cord Stimulation: Different and Common Brain Mechanisms. Neuromodulation. 2016 Jan;19(1):47-59. doi: 10.1111/ner.12368. Epub 2015 Nov 20.

    PubMed 26586145

  • 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

  • Goudman L, Brouns R, De Groote S, De Jaeger M, Huysmans E, Forget P, Moens M. Association Between Spinal Cord Stimulation and Top-Down Nociceptive Inhibition in People With Failed Back Surgery Syndrome: A Cohort Study. Phys Ther. 2019 Jul 1;99(7):915-923. doi: 10.1093/ptj/pzz051.

    PubMed 30916768

Questions about this trial

What is this clinical trial studying?

A study testing EEG recording + pain protocol in people with Failed Back Surgery Syndrome, run by Moens Maarten 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 14 Oct 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?

Functional connectivity (time frame: The change between baseline and 1 month after definitive implantation of the neurostimulator). 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 NCT02751216, which also lists 3 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 14 Oct 2019.

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