Nerve Stimulation for Chronic Pain

(COMFORT 2 Trial)

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

185 Participants Needed

Trial Summary

What is the purpose of this trial?

This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or postsurgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

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 data supports the effectiveness of the treatment Nalu Neurostimulation System for PNS in managing chronic pain?

The Nalu Neurostimulation System is effective in treating chronic pain conditions like post-herniorrhaphy pain syndrome and complex regional pain syndrome, and peripheral nerve stimulation has been successfully used for chronic pain in various body regions, including the lower back and head. ^{1 2 3 4 5}

Is peripheral nerve stimulation safe for treating chronic pain?

Peripheral nerve stimulation, including the Nalu Neurostimulation System, is generally considered safe for treating chronic pain, with studies showing it is less invasive than surgery. However, there can be hardware-related complications that may require revision. ^{1 5 6 7 8}

How is the Nalu Neurostimulation System treatment different from other treatments for chronic pain?

The Nalu Neurostimulation System is unique because it offers a minimally invasive way to deliver peripheral nerve stimulation, which can effectively manage chronic pain by targeting specific nerves with electrical impulses. Unlike traditional surgeries, this system uses image-guided procedures, making it less invasive and potentially reducing recovery time. ^{1 5 9 10 11}

Research Team

Patrick Martin

Principal Investigator

Nalu Medical, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Application of the novel Nalu™ Neurostimulation System for peripheral nerve stimulation. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

An update on peripheral nerve stimulation. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Peripheral nerve field stimulation for chronic pain: 100 cases and review of the literature. [2011]

4. New Zealand pubmed.ncbi.nlm.nih.gov

60-Day PNS Treatment May Improve Identification of Delayed Responders and Delayed Non-Responders to Neurostimulation for Pain Relief. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Analysis of adverse events in the management of chronic migraine by peripheral nerve stimulation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prospective, Multicenter, Randomized, Double-Blinded, Partial Crossover Study to Assess the Safety and Efficacy of the Novel Neuromodulation System in the Treatment of Patients With Chronic Pain of Peripheral Nerve Origin. [2022]

8. New Zealand 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023]