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

Failed Back Surgery Syndrome Clinical Trial

— EEGInspiration  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751216
• Other study ID #: EEGInspiration1
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: January 2018

Study information

• Verified date: October 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

Other:
• EEG recording + pain protocol

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Moens Maarten

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

Moens M, Mariën 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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).
Secondary	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).
Secondary	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
Secondary	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