Nerve Stimulation for Chronic Pain

(COMFORT 2 Trial)

Not currently recruiting at 1 trial location

Overseen By Shilpa Kottalgi, BDS, MAS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nalu Medical, Inc.

Must not be taking: High-dose opioids

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Nalu Neurostimulation System for individuals with chronic nerve pain that persists after surgery or injury. The study compares the effectiveness of this nerve stimulator combined with regular medical care against regular medical care alone. It seeks participants who have experienced severe nerve-related pain for at least six months, particularly in the lower back, shoulder, knee, or foot, and who currently manage their pain with stable medication use. As an unphased trial, this study provides an opportunity to explore innovative pain management solutions beyond the current standard of care.

Will I have to stop taking my current medications?

The trial 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, which suggests you may continue your current medications if they are stable.

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

Research has shown that the Nalu Neurostimulation System for Peripheral Nerve Stimulation (PNS) is generally well-tolerated. In one study, 88% of patients experienced significant and lasting pain relief. However, this treatment carries some risks. The most common side effects include infection, movement of the device, and skin damage. The system is approved for managing severe, long-term nerve pain in adults, indicating that its safety is well-understood and considered acceptable for use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Nalu Neurostimulation System for peripheral nerve stimulation (PNS) is unique because it directly targets nerves that transmit pain signals, offering a more precise treatment for chronic pain compared to conventional methods like medication or physical therapy. Unlike standard treatments that often involve systemic drugs with potential side effects, this system uses electrical impulses to modulate nerve activity, potentially reducing pain without medication. Researchers are excited about this treatment because it could provide pain relief with fewer side effects and improve quality of life for those suffering from chronic pain.

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

Research has shown that the Nalu Neurostimulation System, which participants in this trial may receive, effectively manages chronic pain. In one study, patients using this system experienced lasting pain relief for over a year. The device sends gentle electrical pulses to nerves, blocking pain signals from reaching the brain. This treatment also improves patients' ability to perform daily activities and significantly reduces healthcare costs related to chronic pain. These findings strongly support the system's effectiveness in reducing pain from nerve damage after injury or surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Patrick Martin

Principal Investigator

Nalu Medical, Inc.

Are You a Good Fit for This Trial?

Adults aged 18-80 with chronic, intractable peripheral neuropathic pain not including the face, who have a pain score of at least 6 and stable pain for 60 days. They must be on consistent pain medication for 30 days and cannot have an active implantable device or certain medical conditions that would interfere with the study.

Inclusion Criteria

You are mentally ready to get a nerve stimulator and don't have any psychological conditions that would affect your ability to report your experiences or complete the study tasks.

I would have been prescribed PNS therapy even if I wasn't joining this study.

My pain level in the target area is at least a 6 out of 10.

Exclusion Criteria

I have had a procedure to treat a nerve or its roots for pain relief.

I do not have uncontrolled depression or psychiatric disorders.

I have a diagnosed nerve pain condition like CRPS or neuropathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation and Randomization

Consented subjects receive a baseline evaluation and are randomized into one of two arms: PNS+CMM or CMM alone

1 week

Trial Implant Period

Subjects in Arm 1 undergo a trial implant period using best clinical practices

3 months

Permanent Implant and Follow-up

Subjects who pass the trial implant receive the permanent implant and are followed for a total of 12 months

12 months

Crossover Option for Arm 2

At the 3-month endpoint, subjects in Arm 2 have the option to crossover into Arm 1 beginning with a trial implant

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 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 conventional medical management against conventional medical management alone to treat chronic peripheral neuralgia from post-traumatic or postsurgical origins. It's a controlled trial where participants are randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: PNS Therapy plus Conventional Medical Management (CMM) Active Control 2 Interventions

Subjects in this arm will receive a peripheral nerve stimulator and conventional medical management

Group II: Conventional Medical Management Active Control 1 Intervention

Subjects will receive only CMM

Who Is Running the Clinical Trial?

Nalu Medical, Inc.

Lead Sponsor

Trials

3

Recruited

380+

Published Research Related to This Trial

Peripheral nerve stimulation (PNS) is a safe and effective treatment for chronic pain, showing significant reductions in patient-reported pain scores from an average of around 7.4 to approximately 1.6 within the first month and sustained relief for up to 24 months across 57 patients.

Patients also experienced a notable decrease in their use of morphine, indicating that PNS not only alleviates pain but may also reduce reliance on opioid medications, with significant reductions observed at 6, 12, and 24 months post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Peripheral Nerve Stimulation with a High Frequency Electromagnetic Coupled (HF-EMC) Powered Implanted Receiver in Treating Different Pain Targets/Neuralgias. Abd-Elsayed, A., Moghim, R.[2023]

Peripheral nerve stimulation (PNS) is an effective technique for managing various types of chronic and acute pain by using electrical stimulation to inhibit pain signal transmission in both central and peripheral pathways.

PNS works by inhibiting specific pain fibers in the central nervous system and downregulating inflammatory mediators and neurotransmitters involved in pain signaling, making it a versatile option for treating conditions like post-surgical pain, headaches, and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]

A new training curriculum for Peripheral Nerve Stimulation (PNS) has been developed by a multidisciplinary task force to standardize education and improve proficiency in this effective treatment for chronic pain.

The curriculum includes defined milestones for learners at different levels (early, advanced, and practitioner) and covers essential skills such as professionalism, medical knowledge, and procedural skills, ensuring comprehensive training in PNS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. Kalia, H., Abd-Elsayed, A., Malinowski, M., et al.[2023]

Peripheral nerve stimulation (PNS) has gained significant acceptance in treating chronic pain, with recent multicenter studies leading to its approval in Europe for chronic low back pain and intractable migraines.

The article aims to provide an updated overview of PNS, highlighting its safety and efficacy, as well as the need for further evidence to support its global regulatory approval and optimize treatment parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on peripheral nerve stimulation. Rasskazoff, SY., Slavin, KV.[2017]

Implanting the pulse generator (IPG) closer to the lead location, such as in the infraclavicular region, significantly reduces the incidence of adverse events (AEs) related to peripheral nerve stimulation (PNS) for chronic migraine management, indicating a safer surgical approach.

Increased experience of the implanter, measured by the number of prior PNS implants performed, is associated with a lower rate of stimulation- and hardware-related AEs, suggesting that skill and precision improve with practice, leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. Sharan, A., Huh, B., Narouze, S., et al.[2022]

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]

The distal to proximal neurostimulator lead revision technique is a safe and effective method for adjusting lead positions in patients with chronic pain, as demonstrated in a case series of 3 patients.

All patients experienced over 50% pain reduction at long-term follow-up, indicating that this technique can provide significant relief without the need for replacing the entire neurostimulator system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. Mammis, A., Mogilner, AY.[2014]

External noninvasive peripheral nerve stimulation (EN-PNS) showed significant short-term pain relief in patients with refractory neuropathic pain, with an average reduction of 2.8 points on a numerical rating scale after treatment.

In a study of 20 patients, 40% experienced improvements in quality of life and function, indicating that EN-PNS may be a beneficial option for managing chronic pain, although further controlled studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. Johnson, S., Ayling, H., Sharma, M., et al.[2022]

In a study of 100 patients with chronic intractable pain, peripheral nerve field stimulation (PNFS) led to an average pain reduction of 4.2 points on an 11-point scale, indicating significant efficacy in pain management.

The treatment was safe, with no long-term complications reported, and 72% of patients reduced their use of analgesics after PNFS, highlighting its potential to improve quality of life and change pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. Verrills, P., Vivian, D., Mitchell, B., et al.[2011]

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) The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain.

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

Design of a Multicenter, Randomized Controlled Trial for the ... The Nalu Neurostimulation System for PNS is indicated for pain management in adults who have severe intractable, chronic pain of peripheral ...

3. 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 ... The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain.

4. om1.com om1.com/resource/nalu-pns-system-significantly-reduces-healthcare-related-costs-in-chronic-pain-patients/

Nalu PNS System Significantly Reduces Healthcare ... - OM1 “These findings show that the Nalu PNS System not only improves patients' lives by reducing chronic pain, but also significantly reduces ...

5. firstwordpharma.com firstwordpharma.com/story/5986609

Nalu Announces Publication of Results from COMFORT 2 ... These results confirm the positive clinical outcomes from the COMFORT trial, the first Nalu PNS RCT, and provide the first Level-1 confirmatory ...

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 ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232415.pdf

August 21, 2024 Nalu Medical, Inc. Chelsea Gutierrez Vice ... This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole ...