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

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.

Study Overview

• Status: Completed
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: Other: EEG recording + pain protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Brussels, Vlaams Brabant, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: spinal cord stimulation	Other: EEG recording + pain protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional connectivity	EEG recordings to measure functional connectivity in the brain	The change between baseline and 1 month after definitive implantation of the neurostimulator

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The change between baseline and 1 month after definitive implantation of the neurostimulator
Visual Analogue Scale (VAS) pain diary		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).
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	The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation).
Pain Catastrophizing	Pain catastrophizing is assess be using the 'pain catastrophizing scale'.	The change between baseline and 1 month after definitive implantation of the neurostimulator
Subjective sleep quality	Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).	The change between baseline and 1 month after definitive implantation of the neurostimulator

Collaborators and Investigators

• Sponsor: Moens Maarten
• Investigators: Principal Investigator: Maarten Moens, Prof. dr., Universitair Ziekenhuis Brussel

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: EEG; conditioned pain modulation; high frequency / high density spinal cord stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Back Pain; Syndrome; Failed Back Surgery Syndrome
• Other Study ID Numbers: EEGInspiration1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No