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CompletedNCT02751216EEGInspirationUpdated Oct 14, 2019

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

An interventional study of EEG recording + pain protocol in Failed Back Surgery Syndrome, sponsored by Moens Maarten. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-14.

Sponsored by Moens Maarten · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Failed Back Surgery Syndrome

Keywords

  • high frequency / high density spinal cord stimulation
  • EEG
  • conditioned pain modulation
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 6,515 interventional studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Moens Maarten is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
  2. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
  3. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator, deep brain stimulator or intrathecal drug pump
  4. Subject is unable to operate the device or has no relative available.
  5. Subjects with indwelling devices that may pose an increased risk of infection
  6. Subjects currently has an active infection
  7. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
  8. Subject has participated in another clinical investigation within 30 days
  9. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
  10. Subject has been diagnosed with cancer in the past 2 years
  11. Life expectancy \< 6 months
  12. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
  13. Existing extreme fear for entering MRI
  14. General contraindication for MRI (pacemaker, etc...)
  15. Age male/female patient \<18 years
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    spinal cord stimulation

    Other: EEG recording + pain protocol

Interventions

  • OtherEEG recording + pain protocol
06

What researchers measure

Primary outcomes

  1. Functional connectivity

    EEG recordings to measure functional connectivity in the brain

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

Secondary outcomes

  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

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

  2. Visual Analogue Scale (VAS) pain diary

    Time frame: 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

    Time frame: 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'.

    Time frame: 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).

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

07

Study locations

1 site
  • UZ Brussel
    Brussels, Vlaams Brabant 1090, Belgium
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02751216
Lead sponsor
Moens Maarten
Responsible party
Moens Maarten (Prof. dr., Universitair Ziekenhuis Brussel) — Sponsor-investigator
First posted
Apr 26, 2016
Start date
May 2016
Primary completion
Dec 2017
Completion
Jan 2018
Last update
Oct 14, 2019

Study contacts

Maarten Moens, Prof. dr.
principal investigator · Universitair Ziekenhuis Brussel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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