STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation

Failed Back Surgery Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650362
• Other study ID #: TACTIC1
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2018

Study information

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

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Intervention

Other:
• fMRI

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels	Vlaams Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Nevro

Country where clinical trial is conducted

Belgium, 

References & 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. — View 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. — View 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. Review. — View 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. — 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

Moens M, Sunaert S, Mariën 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. — View 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. German. — View Citation

Stancák A, Kozák J, Vrba I, Tintera J, Vrána J, Polácek H, Stancák 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. Epub 2007 Oct 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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
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 change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
Secondary	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).
Secondary	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).
Secondary	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).