A novel miniature, wireless neurostimulator in the management of chronic craniofacial pain: Preliminary results from a prospective pilot study

Weiner, Richard L.; García, Carlos Montes; Vanquathem, Niek

doi:10.1016/j.sjpain.2017.09.010

Cited by 20 publications

(19 citation statements)

References 25 publications

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“…In clinical scenario, successful wireless stimulation and significant pain relief was observed in patients with back pain, leg pain, neuralgia following herpes zoster, craniofacial pain, occipital neuralgia, and complex regional pain syndrome [17][18][19][20]. Adverse events or complications in these short case series and reports were minimal.…”

Section: Discussionmentioning

confidence: 81%

Wireless Novel Nanotechnology in Neuromodulation of Chronic Pain: A Safe Minimally Invasive, Effective Treatment Option

Perryman

2018

BJSTR

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Nearly 90 million Americans suffer from chronic back pain and eventually get habituated to opioid pain medication hoping for long term relief. Spinal cord stimulation (SCS) evolved over 4 decades as an alternative and effective pain management therapeutic modality, especially in failed back surgery syndrome (FBSS). However technology limitations due to the bulk of the equipment and the limited frequency utilized in the stimulation restricted SCS applications. Over the past few years several advancements in nanotechnology and innovative minimally invasive surgical techniques have shown promising results. They also have a potential for less tissue damage, reduced hospital time and health care costs. Aim:In this article, we introduce a minimally invasive nanotechnology wireless SCS system that has a wide range of frequency of stimulation and wider applications in pain management. Material:We introduce the basis for nanotechnology stimulation and the preliminary experience with wider applications of wireless Neuromodulation for the relief of chronic pain in multiple clinical trials and case illustrations. Results:The equipment utilizes a miniature stimulator device with microelectronics, percutaneously placed at the appropriate stimulation target. This is controlled by a wireless extracorporeal power generator to provide the required stimulation as moderated by the clinician and the patient. This wireless device has been so far clinically used in several chronic pain conditions like FBSS, facial pain, chronic regional pain syndrome and post herpetic neuralgia. Results have been very encouraging and devoid of complications related to implantable power generator (IPG) and its accessories. Few migrations occurred in a small number of patients and this has been the only possible complication of this technique indicating further refinements of the technology. Conclusion:The nanotechnology and wireless devices have reduced the bulk of the implantable SCS equipment to a single electrode (with embedded sensors) due to the present day improved neural-electric interface (in place of brain-machine interface). Thus, they have become minimally invasive with less tissue trauma, fewer hospital hours, reduced hospital visits and better cosmetic results. Further studies with more evaluation metrics in larger groups of studies, however, are required for wider acceptance.

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Section: Discussionmentioning

confidence: 81%

Wireless Novel Nanotechnology in Neuromodulation of Chronic Pain: A Safe Minimally Invasive, Effective Treatment Option

Perryman

2018

BJSTR

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“…Outcome was measured simply in terms of whether or not patients were satisfied with the results; on this basis, 90% of implanted cases were successful at 1 year, although by three years this had fallen to 51%. Weiner et al reported on ten patients implanted with a novel wirelessly powered percutaneous device, who obtained a mean 82% pain relief.…”

Section: Discussionmentioning

confidence: 99%

“…Where all these measures are ineffective, or where medication causes intolerable side-effects, neuromodulation may be an option. Stimulation has been applied at a range of sites, including peripherally using subcutaneous electrodes in the face (2)(3)(4)(5)(6)(7)(8)(9), at the Gasserian ganglion (10)(11)(12), and centrally with high cervical spinal cord stimulation (targeting the spinal trigeminal nucleus) (13)(14)(15), deep brain stimulation (16) (targeting the ventroposteromedial nucleus of the thalamus and/or the periaqueductal gray matter), or motor cortex stimulation (17)(18)(19).…”

Section: Introductionmentioning

confidence: 99%

Burst or Conventional Peripheral Nerve Field Stimulation for Treatment of Neuropathic Facial Pain

Manning

Ortega

Moir

et al. 2019

Neuromodulation: Technology at the Neural Interface

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Background Trigeminal Neuropathic Pain (TNP) is a chronic facial pain syndrome caused by a lesion or disease affecting one or more branches of the trigeminal nerve. It may, for example, result from accidental injury to a branch of the trigeminal nerve by trauma or during surgery; it may also be idiopathic. TNP is typically constant, in contrast to most cases of the commoner trigeminal neuralgia. In some cases, pain may be refractory to pharmacological treatment. Peripheral nerve field stimulation is recognized as an effective minimally invasive surgical treatment option for this debilitating condition. To date, stimulation has used conventional tonic waveforms, which generate paraesthesia in the stimulated area. This is the first report of the use of paraesthesia‐free burst pattern stimulation for TNP. Methods Seven patients were treated at the John Radcliffe Hospital for TNP from 2016 to 2018. Mean duration of preoperative symptoms was five years. All patients had exhausted pharmacological measures to limited effect. The initial three patients had tonic stimulation with the subsequent four having burst stimulation. Outcome was assessed using the numeric pain rating scale preoperatively and postoperatively at three and six months and one year. Side‐effects and complications were also assessed as well as reduction in analgesic medication use. Results All patients achieved pain reduction of at least 50% at 6 months (range 50–100%, mean 81%, p = 0.0082). Those in the burst stimulation group were paraesthesia free. One patient developed a postoperative infection for which the system had to be removed and is awaiting reimplantation. There were no other complications in either group. Conclusion Burst stimulation conferred similar pain control to tonic stimulation in our small cohort, and there were similar reductions in pain medication use. An additional benefit of burst stimulation is freedom from paraesthesia. Larger scale studies are needed to further evaluate burst stimulation and compare its efficacy with that of tonic stimulation.

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“…The dipole antenna of the wireless system (at 915 MHz) could energize the stimulators implanted at a depth of 12 cm in porcine models, especially efficient with a 4.3 cm antenna. Successful stimulation has been observed to provide significant pain relief in patients with back and leg pain with FBSS [19,20], post herpetic neuralgia [21], refractory craniofacial pain [22], occipital neuralgia [23], and CRPS [24]. Patients undergo implantation of the INS with integrated microcircuits enabling coupling with a pulse generator, while the wireless pulse generator circuit excludes surgical implantation of the IPG, thus eliminating complications related to multiple surgical incisions and interventions for failed IPG or its extension cables.…”

Section: Discussionmentioning

confidence: 99%

“…Information in the chapter includes material from the patent applications. Author has copyrights on the publications referenced [18,19,22,23].…”

mentioning

confidence: 99%

Wireless Neuromodulation: From Bench to Bedside

Perryman¹

2019

From Conventional to Innovative Approaches for Pain Treatment

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Spinal cord stimulation (SCS), as a neuromodulation therapy, has rapidly evolved over the past few decades to become the treatment of choice for many chronic pain syndromes. However, many equipment-related limitations such as the bulk of the equipment, an implantable pulse generator (IPG), the limited therapeutic stimulation frequency utilized, and the potential adverse events have restricted SCS applications. Recently, advanced nanotechnology and minimally invasive surgical techniques have shown promising options to expand the indications due to reduced surgical trauma/hospital time/costs. We describe the basis for nanotechnology neuromodulation and the preliminary experience with wireless SCS in the treatment of chronic pain conditions. The equipment utilizes a miniature stimulator with microelectronics, percutaneously placed at the appropriate stimulation target, with wireless control to provide the desired stimulation, and then moderated by the clinician and the patient. The wireless device reduces the bulk of the SCS equipment to a single electrode (with embedded sensors), using the new improved neuralelectric interface. This wireless neuromodulation (WNM) has been clinically used in several chronic pain conditions, including failed back surgery syndrome, facial pain, chronic regional pain syndrome, and postherpetic neuralgia, with encouraging outcome, without the complications of a traditional SCS resulting from the IPG or its accessories.to enhance the quality of neuromodulation in the field of functional neurosurgery and pain management therapies. Wireless neuromodulation, so far applied as SCS, DRG, and PNS, has provided efficient pain relief in cases of FBSS, neuralgic pain, CRPS, and facial pain syndromes. The results observed in small case series or case illustrations are comparable to traditional SCS methods and devoid of many of the complications of TSCS, primarily related to IPG/battery accessories. Further wireless neuromodulation experience may demonstrate improved quality of life associated with significant reduction in cost as well as reduction in complications, with improved cosmetic and functional results. Copyright information

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A novel miniature, wireless neurostimulator in the management of chronic craniofacial pain: Preliminary results from a prospective pilot study

Abstract: AbstractObjectiveTo report a novel wireless neuromodulation system for treatment of refractory craniofacial pain.BackgroundPrevious studies utilizing peripheral nerve stimulation (PNS) of the occipital and trigeminal nerves reported positive outcomes for a… Show more

Cited by 20 publications

References 25 publications

Wireless Novel Nanotechnology in Neuromodulation of Chronic Pain: A Safe Minimally Invasive, Effective Treatment Option

Wireless Novel Nanotechnology in Neuromodulation of Chronic Pain: A Safe Minimally Invasive, Effective Treatment Option

Burst or Conventional Peripheral Nerve Field Stimulation for Treatment of Neuropathic Facial Pain

Wireless Neuromodulation: From Bench to Bedside

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