STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation

NCT02650362 | Completed

• 1 other identifier: TACTIC1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Failed Back Surgery Syndrome

Keywords

spinal cord stimulation; resting state functional magnetic resonance; voxel-based magnetic resonance morphometry

Outcome Measures

Primary Outcomes (2)

• Grey Mater Volume assessed by Voxel-based morphometry analysis (based on MRI images)

  The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

• Functional connectivity analysis using in-house developed software (based on MRI images)

  The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

Secondary Outcomes (5)

• Visual Analogue Scale (VAS) pain diary

  Three times every day (morning, afternoon and evening), starting 1 week before baseline measurements up to 2 months until study completion

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

  The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

• Subjective sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)

  The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

• Pain catastrophizing is assessed by the Pain Catastrophizing Scale (PCS)

  The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

• Likert-scale in order to evaluate the satisfaction grade of the patient.

  The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).

Study Arms (1)

spinal cord stimulation

EXPERIMENTAL

Other: fMRI

Interventions

fMRI OTHER

spinal cord stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Nevro: collaborator

Study Sites (1)

UZ Brussel

Brussels, Vlaams Brabant, 1090, Belgium

Location

Related Publications (8)

• 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.

  PMID: 25257382 BACKGROUND

• 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.

  PMID: 25395117 BACKGROUND

• 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.

  PMID: 24308759 BACKGROUND

• 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.

  PMID: 15770488 BACKGROUND

• 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.

  PMID: 17977762 BACKGROUND

• 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.

  PMID: 22941431 BACKGROUND

• 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.

  PMID: 22018720 BACKGROUND

• 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.

  PMID: 23665999 BACKGROUND

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof dr.

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: January 8, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

BE (1)