Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System

(nPower™-US Trial)

Recruiting at 7 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

110 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a small device that sends electrical signals to reduce chronic leg and back pain in adults who still have pain after back surgery. The device works by changing how pain signals are sent to the brain. This method has been shown to be effective in reducing leg and back pain, especially in patients who have not found relief from previous back surgeries.

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 data supports the effectiveness of the treatment Nalu Neurostimulation System?

The Nalu Neurostimulation System is effective in treating chronic pain conditions like post-herniorrhaphy pain syndrome, intercostal neuralgia, post-laminectomy syndrome, and complex regional pain syndrome, showing promise for managing peripheral neuropathic pain. ^{1 2 3 4 5}

What safety data exists for the Nalu Neurostimulation System or similar treatments?

The available research does not provide specific safety data for the Nalu Neurostimulation System or similar treatments. However, general safety pharmacology studies focus on assessing potential adverse effects on the central nervous system, heart, and lungs before human trials, ensuring that any drug-induced effects are identified early. ^{6 7 8 9 10}

How does the Nalu Neurostimulation System treatment differ from other treatments for this condition?

The Nalu Neurostimulation System is unique because it uses electrical stimulation to modulate neural activity, which can be customized in real-time to optimize therapeutic effects. This closed-loop system adjusts stimulation based on the patient's physiological state, potentially offering more precise and effective treatment compared to traditional open-loop neurostimulation therapies. ^{11 12 13 14 15}

Research Team

Patrick Martin

Principal Investigator

Nalu Medical

Eligibility Criteria

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

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)

Treatment Details

Interventions

• Nalu Neurostimulation System

Participant Groups

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+

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]

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]

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]

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]

References

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

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

2. France pubmed.ncbi.nlm.nih.gov

Neurostimulation options for failed back surgery syndrome: The need for rational and objective measurements. Proposal of an international clinical network using an integrated database and health economic analysis: the PROBACK network. [2016]

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

The Neurostimulation Appropriateness Consensus Committee (NACC) Recommendations for Infection Prevention and Management. [2022]

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

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury. [2022]

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

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations for Surgical Technique for Spinal Cord Stimulation. [2022]

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

Is there a role for the no observed adverse effect level in safety pharmacology? [2021]

7. United States 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. [2018]

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

CNS Safety Screening Under ICH S7A Guidelines Requires Observations of Multiple Behavioral Units to Assess Motor Function. [2020]

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

Categorization of Abuse Potential-Related Adverse Events. [2019]

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

Neurofunctional test batteries in safety pharmacology - Current and emerging considerations for the drug development process. [2020]

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

Neural acupuncture unit: a new concept for interpreting effects and mechanisms of acupuncture. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Neurostimulation Devices for the Treatment of Neurologic Disorders. [2018]

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

Closed-Loop Neuromodulation in Physiological and Translational Research. [2021]

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

Long-Term Surface Electrode Impedance Recordings Associated with Gliosis for a Closed-Loop Neurostimulation Device. [2022]

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

A Novel Robotic-Assisted Technique to Implant the Responsive Neurostimulation System. [2021]