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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02751216
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Moens Maarten, Universitair Ziekenhuis Brussel

Tracking Information
First Submitted Date  ICMJE April 18, 2016
First Posted Date  ICMJE April 26, 2016
Last Update Posted Date October 14, 2019
Study Start Date  ICMJE May 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
Functional connectivity [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]
EEG recordings to measure functional connectivity in the brain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
  • Functioning of the descending inhibitory pathway [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]
    Functioning of the descending pathway will be measured with the conditioned pain modulation paradigm by using electrical stimulation and cold water
  • 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). ]
  • Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics). [ Time Frame: The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation). ]
    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
  • Pain Catastrophizing [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]
    Pain catastrophizing is assess be using the 'pain catastrophizing scale'.
  • Subjective sleep quality [ Time Frame: The change between baseline and 1 month after definitive implantation of the neurostimulator ]
    Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome
Official Title  ICMJE EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Failed Back Surgery Syndrome
Intervention  ICMJE Other: EEG recording + pain protocol
Study Arms  ICMJE Experimental: spinal cord stimulation
Intervention: Other: EEG recording + pain protocol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2016)
6
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02751216
Other Study ID Numbers  ICMJE EEGInspiration1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Moens Maarten, Universitair Ziekenhuis Brussel
Study Sponsor  ICMJE Moens Maarten
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maarten Moens, Prof. dr. Universitair Ziekenhuis Brussel
PRS Account Universitair Ziekenhuis Brussel
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP