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

NCT02751216 | Completed

• 1 other identifier: EEGInspiration1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Failed Back Surgery Syndrome

Keywords

high frequency / high density spinal cord stimulation; EEG; conditioned pain modulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functioning of the descending inhibitory pathway

  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).

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

• Pain Catastrophizing

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

• Subjective sleep quality

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

Study Arms (1)

spinal cord stimulation

EXPERIMENTAL

Other: EEG recording + pain protocol

Interventions

EEG recording + pain protocol OTHER

spinal cord stimulation

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Moens Maarten: lead

Study Sites (1)

UZ Brussel

Brussels, Vlaams Brabant, 1090, Belgium

Location

Related Publications (3)

• 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.

  PMID: 26586145 BACKGROUND

• 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.

  PMID: 23665999 BACKGROUND

• 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.

  PMID: 30916768 DERIVED

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

Study Officials

• Maarten Moens, Prof. dr.

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 26, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 14, 2019

Record last verified: 2019-10

Locations

BE (1)