Micro-Implantable Pulse Generator for Chronic Pain

(COMFORT Trial)

Recruiting at 4 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

89 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 post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

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 data supports the effectiveness of this treatment for chronic pain?

The Nalu Neurostimulation System is shown to be effective in treating chronic pain conditions like post-herniorrhaphy pain syndrome and complex regional pain syndrome, offering reliable peripheral nerve stimulation therapy. Additionally, spinal cord stimulation, a similar approach, has been effective in providing significant pain relief and improving daily activities for patients with chronic pain. ^{1 2 3 4 5}

Is the Nalu Neurostimulation System safe for humans?

The Nalu Neurostimulation System is described as a minimally invasive device for chronic pain management, suggesting it has a safer side effect profile compared to more invasive procedures. ^{1 6 7 8 9}

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

The Nalu Neurostimulation System is unique because it uses a micro-implantable pulse generator for peripheral nerve stimulation, which is smaller and can be placed closer to the nerve, potentially improving effectiveness and comfort compared to larger devices. It also offers wireless control and programmability, allowing for personalized treatment settings. ^{10 11 12 13 14}

Research Team

Patrick Martin

Principal Investigator

Nalu Medical

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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 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 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]

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]

References

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

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

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

Treatment of chronic, intractable pain with a conventional implantable pulse generator: a meta-analysis of 4 clinical studies. [2012]

3. Austria pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation: lead position monitoring by reconstruction CT angiography--a technical report. [2016]

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

Spinal cord stimulation for chronic, intractable pain: superiority of "multi-channel" devices. [2021]

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

Wireless Neuromodulation for Chronic Back Pain: Delivery of High-Frequency Dorsal Root Ganglion Stimulation by a Minimally Invasive Technique. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial. [2021]

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

A Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy. [2020]

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

Reduced Pain and Improved Function Following Short-Term Use of Noninvasive BioWave High Frequency Peripheral Nerve Stimulation for Pain Management. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial. [2023]

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

Peripheral Nerve Stimulation in the Treatment of Chronic Pain Syndromes From Nerve Injury: A Multicenter Observational Study. [2022]

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

A mm-Sized Wireless Implantable Device for Electrical Stimulation of Peripheral Nerves. [2018]

12. Switzerland pubmed.ncbi.nlm.nih.gov

A Versatile Hermetically Sealed Microelectronic Implant for Peripheral Nerve Stimulation Applications. [2021]

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

Wireless microstimulators for neural prosthetics. [2021]

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

Energy efficient neural stimulation: coupling circuit design and membrane biophysics. [2021]