Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nevro | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spinal cord stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fMRI | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Vlaams Brabant | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25257382 | Background | 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. | |
| 25395117 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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). |
| 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). |
| 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. |
| 24308759 | 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. |
| 15770488 | 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. |
| 17977762 | 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. |
| 22941431 | 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. |
| 22018720 | 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. |
| 23665999 | 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. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |