Comparative Study in Patients With Refractory Chronic Lower Limb Neuropathic Pain and/or Back Neuropathic Pain.

Summary

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.

Conditions

• Pain, Neuropathic

Interventions

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.

Sponsors & Collaborators

• Poitiers University Hospital

  lead OTHER

Principal Investigators

• Philippe RIGOARD, MD, PhD · Poitiers Hospital University

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-20

Primary Completion

2022-12-15

Completion

2022-12-15

Countries

• France

Study Locations