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STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation (TACTIC)

Primary Purpose

Failed Back Surgery Syndrome

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
fMRI
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring spinal cord stimulation, resting state functional magnetic resonance, voxel-based magnetic resonance morphometry

Eligibility Criteria

18 Years - undefined (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 back pain (visual analogue scale (VAS) > 5).
  • 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
  • Subject 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

Grey Mater Volume assessed by Voxel-based morphometry analysis (based on MRI images)
Functional connectivity analysis using in-house developed software (based on MRI images)

Secondary Outcome Measures

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
Subjective sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)
Pain catastrophizing is assessed by the Pain Catastrophizing Scale (PCS)
Likert-scale in order to evaluate the satisfaction grade of the patient.

Full Information

First Posted
December 24, 2015
Last Updated
April 16, 2019
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Nevro
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1. Study Identification

Unique Protocol Identification Number
NCT02650362
Brief Title
STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation
Acronym
TACTIC
Official Title
STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation: a Combined Voxel-based Morphometry and Resting State Functional Connectivity Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Nevro

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is an interventional prospective observatory single center trial, investigating the supraspinal effects of long term paresthesia-free high frequency SCS in FBSS patients with back and leg pain completed with resting state functional magnetic resonance (rs fMRI) and voxel-based magnetic resonance morphometry (VBM).
Detailed Description
When patient meets all inclusion criteria and no exclusion criteria, a neuroimaging protocol will be obtained at baseline, prior to trial implantation of SCS. Normal trial period will be respected based on the reimbursement rules in Belgium (4 weeks). When the patient is eligible for implantation of the definitive SCS system (more than 50% pain reduction and/or more than 50% reduction in pain medication), patient will undergo surgery for definitive implantation. After stabilisation of the stimulation parameters at least for more than 1 month, the second session of neuroimaging will occur (T1). Minimal one month later (2 months after implantation of definitive SCS system) the patient will undergo the last session of neuroimaging (T2). The MRI protocol will occur after stabilisation of the stimulation parameters at least for more than 1 month. During the whole period, patients will fill in a VAS diary and at time of neuroimaging T1 and T2 a Likert-scale in order to evaluate the satisfaction grade of the patient. Additionally, patients will also wear 1 month before neuroimaging an Actiwatch, measuring sleep patterns and filling in questionnaires at baseline, T1 and T2 (Pittsburgh Sleep Quality Index (PSQI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
Keywords
spinal cord stimulation, resting state functional magnetic resonance, voxel-based magnetic resonance morphometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spinal cord stimulation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
fMRI
Primary Outcome Measure Information:
Title
Grey Mater Volume assessed by Voxel-based morphometry analysis (based on MRI images)
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Title
Functional connectivity analysis using in-house developed software (based on MRI images)
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) pain diary
Time Frame
Three times every day (morning, afternoon and evening), starting 1 week before baseline measurements up to 2 months until 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 change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Title
Subjective sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Title
Pain catastrophizing is assessed by the Pain Catastrophizing Scale (PCS)
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Title
Likert-scale in order to evaluate the satisfaction grade of the patient.
Time Frame
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 back pain (visual analogue scale (VAS) > 5). 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 Subject 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
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
25257382
Citation
Al-Kaisy A, Palmisani S, Smith T, Harris S, Pang D. The use of 10-kilohertz spinal cord stimulation in a cohort of patients with chronic neuropathic limb pain refractory to medical management. Neuromodulation. 2015 Jan;18(1):18-23; discussion 23. doi: 10.1111/ner.12237. Epub 2014 Sep 25.
Results Reference
background
PubMed Identifier
25395117
Citation
Deer T, Pope J, Hayek S, Narouze S, Patil P, Foreman R, Sharan A, Levy R. Neurostimulation for the treatment of axial back pain: a review of mechanisms, techniques, outcomes, and future advances. Neuromodulation. 2014 Oct;17 Suppl 2:52-68. doi: 10.1111/j.1525-1403.2012.00530.x.
Results Reference
background
PubMed Identifier
24308759
Citation
Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study. Pain Med. 2014 Mar;15(3):347-54. doi: 10.1111/pme.12294. Epub 2013 Dec 5.
Results Reference
background
PubMed Identifier
15770488
Citation
Rasche D, Siebert S, Stippich C, Kress B, Nennig E, Sartor K, Tronnier VM. [Spinal cord stimulation in Failed-Back-Surgery-Syndrome. Preliminary study for the evaluation of therapy by functional magnetic resonance imaging (fMRI)]. Schmerz. 2005 Nov;19(6):497-500, 502-5. doi: 10.1007/s00482-005-0388-9. German.
Results Reference
background
PubMed Identifier
17977762
Citation
Stancak A, Kozak J, Vrba I, Tintera J, Vrana J, Polacek H, Stancak M. Functional magnetic resonance imaging of cerebral activation during spinal cord stimulation in failed back surgery syndrome patients. Eur J Pain. 2008 Feb;12(2):137-48. doi: 10.1016/j.ejpain.2007.03.003. Epub 2007 Oct 30.
Results Reference
background
PubMed Identifier
22941431
Citation
Moens M, Sunaert S, Marien P, Brouns R, De Smedt A, Droogmans S, Van Schuerbeek P, Peeters R, Poelaert J, Nuttin B. Spinal cord stimulation modulates cerebral function: an fMRI study. Neuroradiology. 2012 Dec;54(12):1399-407. doi: 10.1007/s00234-012-1087-8. Epub 2012 Sep 2.
Results Reference
background
PubMed Identifier
22018720
Citation
Moens M, Droogmans S, Spapen H, De Smedt A, Brouns R, Van Schuerbeek P, Luypaert R, Poelaert J, Nuttin B. Feasibility of cerebral magnetic resonance imaging in patients with externalised spinal cord stimulator. Clin Neurol Neurosurg. 2012 Feb;114(2):135-41. doi: 10.1016/j.clineuro.2011.09.013. Epub 2011 Oct 22.
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

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STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation

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