- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02650362
STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation (TACTIC)
STructural And FunCTional Brain Alterations by HIgh FrequenCy Spinal Cord Stimulation: a Combined Voxel-based Morphometry and Resting State Functional Connectivity Study
Study Overview
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vlaams Brabant
-
Brussels, Vlaams Brabant, Belgium, 1090
- UZ Brussel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: spinal cord stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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).
|
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)
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).
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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)
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).
|
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.
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).
|
The change between baseline and 1 month after definitive implantation (T1) and the change between baseline and 2 months after definitive implantation (T2).
|
|
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
|
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)
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).
|
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).
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TACTIC1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Failed Back Surgery Syndrome
-
University of Sao PauloCompletedLow Back Pain | Failed Back Surgery SyndromeBrazil
-
Fundación Universidad Católica de Valencia San...Instituto de Investigación Biomédica de SalamancaNot yet recruitingFailed Back Surgery SyndromeSpain
-
Assiut UniversityNot yet recruitingFailed Back Surgery Syndrome
-
Poitiers University HospitalCompleted
-
Boston Scientific CorporationTerminatedPain | Back Pain | Failed Back Surgery SyndromeUnited States, United Kingdom, Canada, France
-
Moens MaartenCompleted
-
Jaseng Hospital of Korean MedicineCompletedFailed Back Surgery SyndromeKorea, Republic of
-
MedtronicNeuroTerminatedFailed Back Surgery SyndromeFrance, Germany, Belgium, Austria, Netherlands, Australia, Switzerland, United Kingdom, Spain, Israel
-
Poitiers University HospitalCompleted
Clinical Trials on fMRI
-
Weill Medical College of Cornell UniversityMemorial Sloan Kettering Cancer CenterWithdrawnBrain TumorsUnited States
-
Centre Hospitalier Universitaire de Saint EtienneTerminatedMagnetic Resonance Imaging | Neuronal ActivityFrance
-
Centre Hospitalier Universitaire de Saint EtienneUniversity Hospital of Saint-EtienneCompleted
-
Brighton & Sussex Medical SchoolRecruitingDepressionUnited Kingdom
-
Van Boven, Robert W., M.D.Massachusetts Institute of Technology; The Geneva FoundationUnknownTraumatic Brain Injury | Post Traumatic Stress DisorderUnited States
-
Hospices Civils de LyonUniversity of KonstanzCompleted
-
Boston VA Research Institute, Inc.Mclean Hospital; Cambridge Health Alliance; Northeastern UniversityRecruitingSchizophrenia | Treatment-resistant Schizophrenia | Auditory HallucinationUnited States