An interventional study of Spinal Cord Stimulation, association of both (DUAL), Dorsal Root Ganglion stimulation in Pain, Neuropathic, sponsored by Poitiers University Hospital. Terminated at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-13.
Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Screening
Neuropathic pain is described as a "pain initiated or caused by a primary lesion or dysfunction in the nervous system". It is thus often a chronic affection, as a difficult-to-treat condition. As such, there is growing proportion of patients with inefficient pain relief. The prevalence of chronic neuropathic pain has been estimated from 6.9 to 10% in the general population and represents a heavy financial burden for the health care systems. Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain (SCS is a reversible treatment option which leads to improve pain relief and quality of life Using conventional SCS, the prerequisite to target any pain relief is to obtain an appropriate coverage of the painful area with induced paresthesia.
Despite its effectiveness, conventional SCS has some limitations (Selectivity, Energy consumption ...) and in order to address these limitations and challenges, medical devices and neuromodulation industries have developed the Dorsal Root Ganglion (DRG) stimulation. DRG stimulation appears to be a promising technology that can be proposed to patients with chronic neuropathic pain for several reasons: DRG stimulation has shown promising results in pathologies generating focal pain with more selectively than SCS, lead localization appeared to be less discriminative than SCS. Consequently, DRG seems more stable and efficient to relief pain with lower energy consumption than SCS (therapy can be delivered with very low amplitude compared to SCS).
Last but not least, Abbott technology has moved forward to Burst stimulation a couple of years ago and validated this new way of delivering electrical stimulation through several major publications. To our knowledge, applying new waveforms to DRG has not been yet validated. This will represent a fantastic opportunity to refine the design of the next generation of Internal Pulse Generators (IPGs).
To date, the baseline study comparing DRG stimulation to SCS is the ACCURATE study. This is a high quality prospective, multicenter, randomized comparative trial conducted in 152 patients implanted with either SCS or DRG stimulation system. Although ACCURATE study is well designed, it has some limitations.
To bridge this gap, the investigators propose to conduct a randomized controlled trial (RCT) with a crossover design, where SCS and DRG stimulation will be used within patient in three conditions: (i) SCS alone, (ii) DRG stimulation alone (DRGS), (iii) combination of SCS and DRGS (DUAL).
Our goal will be to compare SCS vs DRGS vs DUAL therapies in order to establish the superiority of DRG stimulation over SCS in a crossover design, assess the added value of hybrid stimulation (DUAL) over the separate standalone stimulation types, compare the different cortical pathways involved in both techniques, by functional imaging, incl. MRI, analyze energy consumption by optimizing neural targeting. assess the added value of applying Burst on these different targets, after a 3-month follow-up and to reinforce the perception of neurostimulation techniques through the pain community, as the investigators will demonstrate their benefits on pain relief, functional capacity and quality of life, with objectives measures and a randomized design. This study represents a unique opportunity to boost the rationale of SCS/DRGS since each arm of treatment will be blinded for the patient and the implanter.
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Inclusion Criteria:
Non inclusion criteria:
Other: Spinal Cord Stimulation, association of both (DUAL), Dorsal Root Ganglion stimulation
Other: Spinal Cord Stimulation, association of both (DUAL), Dorsal Root Ganglion stimulation
Other: Spinal Cord Stimulation, association of both (DUAL), Dorsal Root Ganglion stimulation
Other: Spinal Cord Stimulation, association of both (DUAL), Dorsal Root Ganglion stimulation
Other: Spinal Cord Stimulation, association of both (DUAL), Dorsal Root Ganglion stimulation
Other: Spinal Cord Stimulation, association of both (DUAL), Dorsal Root Ganglion stimulation
Lead Implantation which will be conducted in 2 steps: 1. Lead implantation: 8-contact SCS percutaneous lead on SC and 8-contact lead on DRG. 2. Neurostimulation trial phase (Mode DUAL). IPG implantation + Randomization + 1st leads programming (SC, DRG or DUAL stimulation according to randomization sequence). 2nd leads programming (SC, DRG or DUAL stimulation according to randomization sequence). 3rd leads programming (SC, DRG or DUAL stimulation according to randomization sequence). All patients will be switched to Burst waveform for a 1- month follow-up period while keeping the last allocated stimulation type in the randomized crossover arm.
To compare pain relief with SCS vs DRGS vs association of both (DUAL) in patients with chronic lower limb neuropathic pain and/or back neuropathic pain following each stimulation modality within a 3-month crossover period.
Proportion of patients having a reduction of 50% on the Visual Analogic Scale (VAS) score (0-No pain/10-worst pain imaginable) (assessed with a 5-day pain diary) between baseline (before leads implantation) and after the end of each period of crossover phase.
Time frame: 3 Months
Mean pain intensity score
Pain intensity will be assessed using the Visual Analogic Scale (VAS) score (0-No pain/10-worst pain imaginable) at Lead Implantation Visit, M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Mean pain surface (cm²)
Global Pain surface (cm²) measured using a pain mapping tool at Lead Implantation Visit, M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Mean pain surface for each pain intensity (cm²)
Pain intensities associated with the surface measurements measured using a pain mapping tool at Lead Implantation Visit, M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Mean lead performance
Lead performance is measured as the percentage of pain covered with paresthesia at Lead Implantation Visit, M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Mean lead selectivity
Lead selectivity is measured as the percentage of paresthesia covering pain at Lead Implantation Visit, M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Mean discomfort associated with paresthesia.
Discomfort will be assessed using a 11-points NRS (0-no discomfort/10-severe discomfort) at sitting, standing and lying down at M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Mean health-related quality of life score
Health-related quality of life will be assessed using the EuroQol 5-Dimensions index (0-worst imaginable health condition/1-Best Health condition) at Inclusion Visit, M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Mean functional disability score
Functional disability will be assessed using Oswestry Disability Index percentage (0%-the patient can cope with most living activities/100%- These patients are either bed-bound or exaggerating their symptoms.) at Inclusion Visit, M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Mean anxiety and depression scores
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale scores (0 to 14 : no anxiety or depressive disorders/ 15 to 42: existence of anxiety-depressive disorders.) at Inclusion Visit, M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Mean catastrophizing score
Catastrophizing will be assessed using Pain Catastrophizing Scale scores (0 to 52) at Inclusion Visit, M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Patient satisfaction
Satisfaction will be assessed using the Patient Global Impression of Change scale scores (0-No change or it gets worse/ 6-Significantly better, a considerable improvement that makes all the difference) at M0, M1, M2, M3, M4, M6 and M12.
Time frame: 12 months
Percentage of responders as defined by the following composite stimulation efficacy score
Stimulation efficacy is defined as having at least three of the criteria listed below, 12 months following IPG implantation (patients with a negative lead trial will be considered as nonresponders). * Regaining functional capacity: Having at least a 30% decrease in the ODI score. * Adequate global pain relief: Having at least a 50% decrease in the VAS. * Improvement in quality of life: Having at least a 0.2 points increase in the EQ-5D index. * Decrease in psychological distress: Having a decrease of 1.4 points in the HADS depression score. * 30% decrease in pain surface (percentage of cm²) * Having a PGIC score of at least 6. * Drug intake: drug intake will be measured using the Medication Quantification Scale III (MQS) and a reduction of 3.4 points will be considered as meaningful.
Time frame: 12 months
Rate of adverse events
Safety will be evaluated by the rate of Adverse Events (AE), Serious Adverse Events (SAE) and device deficiencies from Inclusion to M12.
Time frame: 12 months
EEG characteristics will be collected, ratio between the dorsal anterior cingulate cortex and pregenual anterior cingulate cortex/ventromedial prefrontal cortex will be measured.
Ratio between the dorsal anterior cingulate cortex (dACC) and pregenual anterior cingulate cortex/ventromedial prefrontal cortex (pgACC/vmPFC) will be measured at inclusion, M3 and M4.
Time frame: 4 months
fMRI characteristics will be collected using Blood Oxygen Level Dependent (BOLD) functional Magnetic Resonance Imaging (fMRI).
Stimulations effects on brain activity will be studied using Blood Oxygen Level Dependent (BOLD) functional Magnetic Resonance Imaging (fMRI). BOLD fMRI response in pain related brain regions such as primary/secondary somatosensory cortex, retrosplenial granular cortex, thalamus, caudate putamen, nucleus accumbens, globus pallidus, and amygdala will be assessed at inclusion, M3 and M4.
Time frame: 4 months
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Poitiers University Hospital