Micro-Implantable Pulse Generator for Chronic Pain

(COMFORT Trial)

Not currently recruiting at 5 trial locations

Overseen By Shilpa Kottalgi, BDS, MAS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nalu Medical, Inc.

Must not be taking: Antidepressants, Anticoagulants

Disqualifiers: Active implantable device, CRPS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a small, implantable device that uses electrical pulses to manage chronic pain from nerve damage due to surgery or injury. The main goal is to determine if this nerve-stimulating device, called the Nalu Neurostimulation System for PNS (Peripheral Nerve Stimulation), combined with usual pain treatments, is more effective than usual pain treatments alone. Individuals with persistent nerve pain in areas such as the back, shoulder, knee, or foot, who find regular pain treatments insufficient, might be suitable for this trial. As an unphased trial, this study provides an opportunity to explore innovative pain management solutions for those seeking alternatives to conventional treatments.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable pain medication use and dosage for 30 days before joining the study.

What prior data suggests that the Nalu Neurostimulation System for PNS is safe for treating chronic pain?

Research shows that the Nalu Neurostimulation System, used for peripheral nerve stimulation (PNS), is generally well-tolerated. Studies have found that patients often experience significant and lasting pain relief with this system. In everyday use, many patients report meaningful long-term pain relief with both temporary and permanent implants.

However, some side effects occur. Common issues include infection, leads moving from their original position, and skin problems. These are important to consider, but such events remain relatively rare.

Overall, while some risks exist, many patients achieve positive results with the Nalu PNS System. It's important to weigh these factors and discuss them with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Nalu Neurostimulation System for PNS because it offers a new way to manage chronic pain by targeting peripheral nerves directly. Unlike standard treatments like opioids or nerve blocks, which can have significant side effects or provide only temporary relief, this system uses a tiny, implantable pulse generator to deliver precise electrical pulses to the nerves, potentially reducing pain with fewer side effects. This innovative delivery method not only aims to provide more consistent pain relief but also minimizes the invasiveness associated with larger implants, making it a promising option for long-term pain management.

What evidence suggests that the Nalu Neurostimulation System for PNS is effective for chronic pain?

Research shows that the Nalu Neurostimulation System helps manage chronic pain by stimulating nerves. Studies have found that people using this system experience long-term pain relief. One study revealed that participants had less pain and improved mobility over a year. The FDA has approved the system, confirming its safety and effectiveness. In this trial, some participants will receive the Nalu Neurostimulation System alongside Conventional Medical Management, while others will receive only Conventional Medical Management. Patients have reported improvements with both temporary and permanent implants. These results suggest that the Nalu system can provide lasting relief for those with chronic nerve pain. ^{2 4 5 6 7}

Who Is on the Research Team?

Patrick Martin

Principal Investigator

Nalu Medical

Are You a Good Fit for This Trial?

Adults aged 18-80 with chronic, intractable peripheral neuropathic pain for at least 6 months, not including the face. Pain must be mainly neuropathic from conditions like nerve injury or osteoarthritis. Participants need a pain score of at least 6 and stable medication use for 30 days. They can't have other active implants, recent successful pain treatments, uncontrolled mental health issues, allergies to device materials, certain medical conditions or be pregnant.

Inclusion Criteria

I can correctly place the adhesive clip or use the relief belt/cuff for the therapy disc.

I would be prescribed PNS therapy even if I wasn't part of this study, and using the Nalu device is appropriate for my condition.

I have been on a stable pain medication plan for the last 30 days.

Exclusion Criteria

I do not experience pain when I am resting.

Subject is currently participating in another clinical investigation with an active treatment arm.

Subject has pending or ongoing legal issues (including unresolved worker's compensation claims or equivalent) or other conflicting secondary gain issues related to their chronic pain condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peripheral nerve stimulation plus conventional medical management or conventional medical management alone

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Medical Management
• Nalu Neurostimulation System for PNS

Trial Overview The trial is testing the Nalu Neurostimulation System plus usual medical care against medical care alone for treating long-term peripheral neuralgia after trauma or surgery. It's a prospective study where participants are randomly assigned to either receive the new treatment or stick with standard care.

How Is the Trial Designed?

Group I: Conventional Medical Management Experimental Treatment 1 Intervention

Control arm conventional medical management only

Group II: PNS Therapy plus Conventional Medical Management Active Control 2 Interventions

peripheral nerve stimulator plus conventional medical management

Who Is Running the Clinical Trial?

Nalu Medical, Inc.

Lead Sponsor

Trials

3

Recruited

380+

Published Research Related to This Trial

The Nalu™ Neurostimulation System represents a significant advancement in peripheral nerve stimulation for chronic neuropathic pain, transitioning from invasive surgeries to minimally invasive procedures.

This device has shown effectiveness in managing various chronic pain conditions, including post-herniorrhaphy pain syndrome and complex regional pain syndrome, indicating its potential as a reliable treatment option for peripheral neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the novel Nalu™ Neurostimulation System for peripheral nerve stimulation. Kalia, H., Pritzlaff, S., Li, AH., et al.[2022]

In a study of 62 patients with chronic pain, spinal cord stimulation provided at least 50% pain relief for many, with improvements in daily activities and reduced need for pain medications, demonstrating its efficacy as a treatment for intractable pain.

The use of multi-channel devices and the presence of stimulation paresthesias over the pain area were significant predictors of successful outcomes, highlighting the importance of device technology and patient-specific factors in achieving pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic, intractable pain: superiority of "multi-channel" devices. North, RB., Ewend, MG., Lawton, MT., et al.[2021]

In a study involving 21 veterans with fibromyalgia, those receiving auricular percutaneous electrical nerve field stimulation (PENFS) showed a trend toward improved pain scores and significant reductions in pain interference with sleep compared to standard therapy alone after 12 weeks.

Neuroimaging results indicated that PENFS treatment was associated with increased connectivity in brain areas related to pain processing and executive control, suggesting a unique mechanism of action for PENFS in managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial. Woodbury, A., Krishnamurthy, V., Gebre, M., et al.[2023]

In a pilot study involving four patients with chronic neuropathic pain, computer tomographic (CT) techniques were successfully used to improve the positioning of peripheral nerve stimulator (PNS) leads, enhancing treatment effectiveness.

The study demonstrated that CT scans can reliably detect the position of implanted nerve electrodes in relation to neurovascular structures, suggesting they are superior to standard X-rays for monitoring lead placements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation: lead position monitoring by reconstruction CT angiography--a technical report. Klase, D., Bischof, A., Haendler, G., et al.[2016]

In a Phase I/II trial involving 14 patients with treatment-resistant fibromyalgia, vagus nerve stimulation (VNS) was found to be generally safe and tolerable, with side effects similar to those seen in epilepsy and depression treatments, including dry mouth and fatigue.

After 3 months of VNS, 5 out of 12 patients showed significant improvement in pain and overall wellness, with some patients even losing their fibromyalgia diagnosis criteria, suggesting VNS could be a promising adjunct treatment for fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial. Lange, G., Janal, MN., Maniker, A., et al.[2021]

Citations

1. nalumed.com nalumed.com/nalu-announces-publication-of-the-largest-long-term-report-of-real-world-data-rwd-on-a-permanent-pns-device/

Publication of the Nalu Real-World Data (RWD) Peripheral Nerve Stimulation — The Nalu PNS System is indicated for pain management in adults who have severe chronic intractable pain of ...

2. nalumed.com nalumed.com/nalu-1-year-pns-data-show-durable-pain-relief-and-significant-functional-improvement/

Nalu 1-Year PNS Data Show Durable Pain Relief and ... It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit www.nalumed.com.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11380855/

Design of a Multicenter, Randomized Controlled Trial for the ... The primary objective of this study is to document the comparative effectiveness and safety of peripheral nerve stimulation (PNS) plus ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11801347/

Real-world long-term outcomes of peripheral nerve stimulation Patients report clinically meaningful long-term pain relief after receiving PNS through both 60-day and permanent implant systems.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05870124

NCT05870124 | Clinical Study of a Micro-Implantable ... This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical ...

6. nalumed.com nalumed.com/nalu-pns-system-achieves-significant-and-durable-pain-reduction-meeting-the-primary-endpoint-of-the-comfort-rct-study/

Nalu PNS System achieves significant and durable pain ... Nalu PNS System achieves significant and durable pain reduction, meeting the primary endpoint of the COMFORT RCT study · CARLSBAD, Calif. · 88% of ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715925000315

An Analysis of the MAUDE Data base and Implications for ... Our analysis of the MAUDE data base revealed that infection, lead migration, and skin erosion were the most commonly reported AEs associated with the use of ...