Nalu Neurostimulation for Chronic Pain

(nPower™-US Trial)

No longer recruiting at 8 trial locations

Overseen By Shilpa Kottalgi, BDS,MAS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nalu Medical, Inc.

Disqualifiers: Active implantable devices, Failed SCS, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Nalu Neurostimulation System to determine if it safely and effectively reduces chronic pain in the back and legs. It targets individuals with failed back surgery syndrome, where surgery did not alleviate their back pain. Eligible participants should have experienced chronic pain for at least six months that has not improved with standard treatments and should feel more nerve-related pain than muscle or joint pain in their legs or back.

As an unphased trial, this study provides a unique opportunity to explore new treatment options for managing chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Nalu Neurostimulation System is safe for treating chronic pain in the legs and back?

Research has shown that the Nalu Neurostimulation System is safe for use. The FDA has approved it for spinal cord and peripheral nerve stimulation, indicating it has passed key safety checks for these applications.

Before receiving this approval, Nalu Medical conducted various tests to confirm the system's safety and effectiveness. These tests ensure the device functions properly without harming users. Like any medical device, some risks or side effects may occur, but FDA approval indicates these remain within acceptable limits.

Overall, the Nalu Neurostimulation System is designed for ease of use, and most people do not experience serious issues with it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Nalu Neurostimulation System is unique because it offers a new way to manage chronic, intractable pain through spinal cord stimulation. Unlike traditional treatments like medications or larger implantable devices, the Nalu system is ultra-miniaturized, making it less invasive and more comfortable for long-term use. Researchers are excited about its potential to offer targeted pain relief with fewer side effects, thanks to its precise and adjustable stimulation capabilities. This could mean a more personalized pain management approach for patients who haven't found relief with existing options.

What evidence suggests that the Nalu Neurostimulation System is effective for chronic pain in the legs and back?

Research has shown that the Nalu Neurostimulation System effectively reduces chronic pain. Studies found that after 12 months, 87% of users experienced more than 50% pain relief, with an average reduction of 73%. The Nalu system sends gentle electrical pulses to the nerves, blocking pain signals from reaching the brain. Real-world data and trials support these positive results, demonstrating significant pain relief and improved function. This treatment targets chronic leg and back pain, particularly for individuals with failed back surgery syndrome (FBSS). All eligible subjects in this trial will receive the Nalu Neurostimulation System. ^{6 7 8 9 10}

Who Is on the Research Team?

Patrick Martin

Principal Investigator

Nalu Medical

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject is between 21 and 80 years of age at enrollment.

Subject has chronic (defined as at least 6 months duration), intractable neuropathic pain of legs and/or back; any nociceptive pain must be less prominent than the neuropathic pain.

Subject's pain is unresponsive to conservative treatment options.

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial

Subjects undergo a trial with the Nalu Neurostimulation System to assess pain reduction

Duration not specified

Permanent Implant

Eligible subjects receive the Nalu Neurostimulation System implant and are programmed for stimulation

3 months

Clinic visits at 1 month and 3 months for follow-up and programming

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nalu Neurostimulation System

How Is the Trial Designed?

Group I: Nalu SCS System Experimental Treatment 1 Intervention

All eligible subjects will receive the Nalu Neurostimulation System

Who Is Running the Clinical Trial?

Nalu Medical, Inc.

Lead Sponsor

Trials

3

Recruited

380+

Published Research Related to This Trial

Regulatory guidelines recommend specialized safety pharmacology assessments in animals to evaluate drug effects on the central nervous system (CNS) before human trials, but the effectiveness of these tests in detecting subtle neurotoxic effects is under scrutiny.

A survey of experts revealed that while certain endpoints in neurofunctional assessments (like convulsions and stereotypic behaviors) are deemed highly impactful, many others are considered less relevant, suggesting a need for a revised approach to improve the translational value of these assessments and potentially reduce animal use without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofunctional test batteries in safety pharmacology - Current and emerging considerations for the drug development process. Jackson, SJ., Authier, S., Brohmann, H., et al.[2020]

In a study involving 16 patients with medically refractory focal epilepsy, robotic-assisted implantation of the responsive neurostimulation system (RNS) led to an impressive average seizure reduction of 82% at 6 months and 90% at 1 year, demonstrating its efficacy as a treatment.

The use of the ROSA robot for targeting ictal-onset zones resulted in a highly accurate lead placement, with only a 0.165-mm discrepancy between the expected and actual lead locations, indicating a precise method for improving seizure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Robotic-Assisted Technique to Implant the Responsive Neurostimulation System. Tran, DK., Paff, M., Mnatsakanyan, L., et al.[2021]

Monitoring brain activity using electroencephalography (EEG) during preclinical toxicology studies can help identify potential central nervous system (CNS) risks early in drug development, which is crucial for ensuring safety before human trials.

There is no single definitive marker for seizure risk in drug testing, but observing behavioral changes and plasma drug levels can help establish safety margins, indicating that a full EEG study may not always be necessary under current regulatory standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A predictive index of biomarkers for ictogenesis from tier I safety pharmacology testing that may warrant tier II EEG studies. Gauvin, DV., Zimmermann, ZJ., Yoder, J., et al.[2018]

A review of 213 terms related to drug abuse potential revealed that most terms (80%) reflect treatment-emergent adverse events rather than behaviors that motivate drug abuse, highlighting the need for careful assessment during drug development.

Only 20% of the terms were considered to indicate a strong potential for reinforcing drug-seeking behavior, suggesting that many reported adverse events may not directly correlate with actual abuse risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Categorization of Abuse Potential-Related Adverse Events. Sellers, EM., Romach, MK.[2019]

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 Neurostimulation Appropriateness Consensus Committee (NACC) aims to enhance the safety of neurostimulation procedures by providing updated recommendations based on expert consensus and best evidence.

The International Neuromodulation Society (INS) has established guidelines that, when followed, are expected to minimize the risk of neurological injuries and complications associated with the surgical implantation of neurostimulation devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury. Deer, TR., Lamer, TJ., Pope, JE., et al.[2022]

The study found that there is no formal definition of 'adversity' or guidance on determining the No Observed Adverse Effect Level (NOAEL) in safety pharmacology, indicating a lack of standardized practices in this area.

It was concluded that using NOAEL in safety pharmacology is not recommended, as the diverse functional endpoints measured do not fit into a simple toxic/non-toxic classification, suggesting a need for more nuanced risk assessments in drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for the no observed adverse effect level in safety pharmacology? Mow, T., Andersen, NK., Dragsted, N., et al.[2021]

Citations

1. 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 ... Nalu 1-Year PNS Data Show Durable Pain Relief and Significant Functional Improvement · Durable Reduction of Pain · Significant Improvement in ...

2. 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.

3. 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 ...

4. 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 ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/nalu-shares-positive-long-term-data-for-chronic-pain-device-at-nans-2024/

Nalu shares positive long-term data for chronic pain ... After 12-months, 87% of subjects using the Nalu system achieved more than 50% pain relief, with a 73% average pain reduction. Go deeper with ...

6. nalumed.com nalumed.com/product-safety-information/

Product Safety Information Product Safety Information. User Manual · Safety Information · Patient Resources · Provider Resources.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K203547.pdf

K203547.pdf - accessdata.fda.gov Nalu Medical performed a range of testing to gather data supporting the safety and performance of the Nalu Neurostimulation System prior to use.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221376.pdf

June 10, 2022 Nalu Medical, Inc. Chelsea Gutierrez VP ... The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation (SCS; K203547) and peripheral nerve stimulation (PNS; ...

9. nalumed.com nalumed.com/product-information/

Product Information The Nalu Neurostimulation System is currently FDA cleared for SCS and PNS indications. The Nalu micro-IPG leverages proprietary advanced microelectronics.

10. mrisafety.com mrisafety.com/TMDL_list.php?mastertable=SafetyInformation&masterkey1=367

Safety Topic [367] Nalu Neurostimulation System, Nalu Medical, www.nalumed.com. The only Nalu Medical components that are labeled and approved as MR Conditional are the Lead ...