Electrical Stimulation for Peripheral Neuropathy
(SELECT Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Epineuron Technologies Inc.
Disqualifiers: Peripheral neuropathy, Active implanted device
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment for peripheral neuropathy?
Research shows that peripheral nerve stimulation (PNS) is effective in treating chronic neuropathic pain, providing significant pain relief where other treatments have failed. Design-specific PNS devices have been reported to offer long-term pain relief, as seen in a case where a patient experienced two years of relief from lower extremity neuropathic pain.
12345Is electrical stimulation for peripheral neuropathy safe for humans?
Peripheral nerve stimulation (PNS) has been used safely since the 1960s for various pain conditions, with recent devices showing favorable safety profiles. The StimRouter system, a type of PNS, is noted for its high safety margin compared to other systems.
16789How does electrical stimulation differ from other treatments for peripheral neuropathy?
Electrical stimulation for peripheral neuropathy is unique because it uses a non-invasive method to deliver electrical pulses to nerves, which can significantly reduce pain. Unlike traditional medications, this treatment directly targets nerve activity and has shown promising results in reducing pain without serious side effects.
1271011Eligibility Criteria
This trial is for individuals with ulnar neuropathy at the elbow, which is a condition affecting the nerve on the inner side of the elbow. It's not suitable for people who have an active implanted device or peripheral neuropathy that affects nerves other than the one of interest.Inclusion Criteria
I have nerve damage in my elbow.
Exclusion Criteria
Patients with any active implanted device
I have nerve damage not related to the nerve being studied.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive standard of care plus a single, 1-hour dose of electrical stimulation
1 hour
Follow-up
Participants are monitored for safety and effectiveness after treatment, including sensory recovery and functional recovery assessments
1.5 years
Participant Groups
The study is testing a new temporary nerve stimulation system designed to be used after surgery for cubital tunnel syndrome. The goal is to see if this electrical stimulation can help improve recovery outcomes.
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Standard of care only.
Group II: Experimental InterventionActive Control1 Intervention
Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hamilton General HospitalHamilton, Canada
St. Joseph's Healthcare HamiltonHamilton, Canada
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Who Is Running the Clinical Trial?
Epineuron Technologies Inc.Lead Sponsor
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)Collaborator
References
Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. [2021]Peripheral nerve stimulation (PNS) is a form of neuromodulation that is used to treat chronic and refractory neuropathic pain. Peripheral nerve stimulation was first described in the early 1960s when Shelden implanted a PNS device for trigeminal neuralgia. Despite PNS being known since the 1960s, technology designed specifically for PNS was lacking. Within the past few years, design-specific PNS devices have become widely available, with favorable efficacy and safety profiles. Here we report a case of design-specific PNS that provided two years of pain relief in a patient with lower extremity neuropathic pain.
Peripheral nerve stimulation in intractable neuropathic pain. [2013]Peripheral nerve stimulation (PNS) is a neurostimulation analgesic technique. PNS is utilized to treat peripheral neuropathic pain. It is highly sophisticated and a specialized technique used where other forms of treatment have failed. This paper describes the PNS procedure, its therapeutic principles, indications, and the comprehensive care for patients after the PNS implant. First, we summarize our experience using this type of invasive treatment. In the second part, a case of intractable neuropathic pain following repeated surgery to the ulnar nerve is reported. Prior to PNS, the patient underwent multiple types of antineuralgic treatment with no significant result. Only after the PNS application, was a significant analgesic effect achieved.
Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. [2023]Peripheral nerve stimulation (PNS) is an effective neuromodulation therapy for chronic neuropathic and nociceptive pain. Although the total number of PNS implantations has increased over the last decade, no curriculum exists to guide training and learning of this therapy. The goal of the North American Neuromodulation Society (NANS) education committee is to develop a series of competency-based curriculums for neuromodulation therapies. The PNS curriculum is the latest part of such series, following the curriculums for spinal cord stimulation and intrathecal drug delivery system.
Feasibility of ultrasound-guided percutaneous placement of peripheral nerve stimulation electrodes in a cadaver model: part one, lower extremity. [2019]Peripheral nerve stimulation (PNS) is analgesic for some lower extremity neuropathic pain syndromes. PNS currently involves open surgical placement of electrode(s). Increasingly, ultrasound guidance is used for perioperative neural block. Minimally invasive placement of PNS electrodes for lower extremity targets using ultrasound guidance has not been reported. We hypothesized that ultrasound-guided placement of PNS electrodes was feasible.
Ultrasound-guided permanent implantation of peripheral nerve stimulation (PNS) system for neuropathic pain of the extremities: original cases and outcomes. [2022]Our objective is to describe our experience applying a minimally invasive, ultrasound-assisted technique for peripheral nerve stimulation (PNS) trial and permanent implantation in patients with neuropathic extremity pain.
A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. [2014]Peripheral nerve stimulation for chronic pain states is a safe and efficacious technique, being used with increasing frequency. The incidence of hardware-related complications requiring revision remains high.
Is electrical stimulation effective in reducing neuropathic pain in patients with diabetes? [2019]Pulsed-dose electrical stimulation is evaluated as an analgesic modality in patients-with painful diabetic neuropathy. Using a knitted silver-plated nylon/dacron stocking electrode, patients were given electrical stimulation over the course of 1 month. Pain was measured weekly, using a 10-cm. visual analog scale. Pain measurements at the end of the 4-week therapy and at 1 month after complete discontinuation of therapy were significantly lower than at the initiation of therapy. The results of this pilot study suggest that nocturnal doses of pulsed-electrical stimulation may be effective in alleviating subjective, burning, diabetic neuropathic pain in a population consisting of patients with grossly intact protective sensation, relatively good distal vascular perfusion and less than ideal glucose control. To the authors' knowledge, this is the first analytic report of pulsed-dose electrical nerve stimulation delivered through a stocking electrode for treatment of symptomatic diabetic neuropathy in medical literature.
Long-term peripheral nerve stimulation for painful nerve injuries. [2019]Although peripheral nerve stimulation (PNS) has been used in the treatment of pain since 1965, only a few follow-up studies have been published. The aim of the present retrospective study was to carefully assess the long-term efficacy and safety of PNS in the treatment of painful nerve injuries.
A review of the StimRouter® peripheral neuromodulation system for chronic pain management. [2021]The StimRouter® peripheral nerve stimulation system created by Bioness, Inc., (CA, USA) is US FDA-approved for the treatment of peripheral mononeuropathy refractory to conservative medical management. StimRouter is a minimally invasive system that utilizes a subcutaneously implanted lead with integrated anchor and electrodes, and an external pulse generator to produce peripheral neuromodulation and achieve pain relief. Multiple published clinical trials reviewed here have shown the StimRouter system to have a high margin of safety, differentiating it from other existing peripheral neuromodulation systems requiring open surgical electrode placement and implantable pulse generators. These studies have also shown the StimRouter system to be efficacious in the treatment of multiple peripheral mononeuropathies; improving patient pain, activity levels and quality of life. StimRouter represents a feasible option for management of chronic peripheral mononeuropathy.
Application of the novel Nalu™ Neurostimulation System for peripheral nerve stimulation. [2022]Peripheral nerve stimulation is an established treatment modality for chronic neuropathic pain. Over the last decade, with the advent of innovative devices and delivery platforms, peripheral nerve stimulation has evolved from invasive open surgeries to image-guided, minimally invasive percutaneous procedures. The authors hereby present a novel device, the Nalu™ Neurostimulation System (Nalu Medical, CA, USA), which has established its advantages in providing predictable and reliable peripheral nerve stimulation therapy for chronic neuropathic pain management. This novel device is effective in treating chronic pain conditions such as post-herniorrhaphy pain syndrome, intercostal neuralgia, post-laminectomy syndrome, and complex regional pain syndrome and holds great promise for the treatment of peripheral neuropathic pain.
Electrical stimulation of the posterior tibial nerve reduces neuropathic pain in patients with polyneuropathy. [2023]Peripheral neuropathic pain (PNP) is caused by neuronal damage to the peripheral nervous system and usually affects the distal extremities. This open-label study examined the effect of short-term peripheral nerve stimulation (PNS) on individuals with PNP due to polyneuropathy. A total of 12 patients (mean age, 63.0 ± 10.0 years, 41.7% male) with daily bilateral PNP for at least 6 months (mean duration, 7.4 ± 7.8 years) received a total of six direct electrical stimulation therapies to the posterior tibial nerve at 3-4-day intervals. Eight patients completed the study and were included in the efficacy analysis. The average pain at baseline was 36.6 ± 3.80 estimated by the Short-Form McGill Pain Questionnaire. After the last stimulation, pain was significantly reduced by 85.5% to 4.88 ± 3.1 (p = 0.008). Six patients (75%) had over 50% decrease in pain after the first stimulation therapy and 99.2% after the final stimulation therapy. The patients also reported statistically significant decreases in pain level (measured by visual analog scale), ranging from 54.85% to 87.50% after each of the stimulations as compared to the pain experienced prior to the stimulations. The procedure was safe without any serious adverse events. PNS has demonstrated excellent efficacy and improvement of PNP symptoms. Further studies in larger patient populations are warranted.