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

Primary Purpose

Failed Back Surgery Syndrome

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

EEG recording + pain protocol

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring high frequency / high density spinal cord stimulation, EEG, conditioned pain modulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

UZ Brussel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

spinal cord stimulation

Arm Description

Outcomes

Primary Outcome Measures

Functional connectivity

EEG recordings to measure functional connectivity in the brain

Secondary Outcome Measures

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

Visual Analogue Scale (VAS) pain diary

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

Pain Catastrophizing

Pain catastrophizing is assess be using the 'pain catastrophizing scale'.

Subjective sleep quality

Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).

Full Information

NCT ID

NCT02751216

First Posted

April 18, 2016

Last Updated

October 10, 2019

Sponsor

Moens Maarten

1. Study Identification

Unique Protocol Identification Number

NCT02751216

Brief Title

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

Acronym

EEGInspiration

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Moens Maarten

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Failed Back Surgery Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

spinal cord stimulation

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

EEG recording + pain protocol

Primary Outcome Measure Information:

Title

Functional connectivity

Description

EEG recordings to measure functional connectivity in the brain

Time Frame

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

Secondary Outcome Measure Information:

Title

Functioning of the descending inhibitory pathway

Description

Functioning of the descending pathway will be measured with the conditioned pain modulation paradigm by using electrical stimulation and cold water

Time Frame

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

Title

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).

Title

Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).

Description

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

Time Frame

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

Title

Pain Catastrophizing

Description

Pain catastrophizing is assess be using the 'pain catastrophizing scale'.

Time Frame

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

Title

Subjective sleep quality

Description

Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maarten Moens, Prof. dr.

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZ Brussel

City

Brussels

State/Province

Vlaams Brabant

ZIP/Postal Code

1090

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

26586145

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.

Results Reference

background

PubMed Identifier

23665999

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.

Results Reference

background

PubMed Identifier

30916768

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.

Results Reference

derived

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

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