Clinical trial NCT02751216: EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome
Official title: EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Keywords: high frequency / high density spinal cord stimulation
EEG
conditioned pain modulation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional connectivity
timeFrame: The change between baseline and 1 month after definitive implantation of the neurostimulator
Secondary outcomes:
measure: Functioning of the descending inhibitory pathway
timeFrame: The change between baseline and 1 month after definitive implantation of the neurostimulator
measure: Visual Analogue Scale (VAS) pain diary
timeFrame: 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).
measure: Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
timeFrame: The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation).
measure: Pain Catastrophizing
timeFrame: The change between baseline and 1 month after definitive implantation of the neurostimulator
measure: Subjective sleep quality
timeFrame: The change between baseline and 1 month after definitive implantation of the neurostimulator
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
state: Vlaams Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Maarten Moens, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.