Peripheral Nerve Regenerative Interface for Neuroma

(NBxPilot Trial)

Not yet recruiting at 2 trial locations

Overseen By Danielle Cohen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Previous nerve trauma

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a treatment called Regenerative Peripheral Nerve Interface (RPNI) during sural nerve biopsies can prevent painful nerve problems known as neuromas. Neuromas can cause discomfort and sometimes require additional surgeries, so preventing them could improve patient care and quality of life. Participants are divided into two groups: one group will undergo only the biopsy, while the other will receive both the biopsy and the RPNI treatment. This trial is suitable for individuals referred for sural nerve and muscle biopsy at the University of British Columbia, provided they have not had previous nerve injuries or surgeries.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the regenerative peripheral nerve interface (RPNI) is safe for use in sural nerve biopsy?

Research has shown that the Regenerative Peripheral Nerve Interface (RPNI) is generally well-tolerated by patients and significantly reduces pain. For example, one study reported a 71% decrease in neuroma pain, a type of nerve pain, and a 53% reduction in phantom pain, the pain felt where a limb has been amputated. Another review found that RPNI can effectively prevent painful neuromas from forming and reduce phantom limb pain. These findings suggest that RPNI is safe, with many patients experiencing less pain after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peripheral Nerve Regenerative Interface (RPNI) for treating neuromas because it offers a novel approach to nerve repair. Unlike traditional treatments, which may involve pain management or surgical removal of the neuroma, RPNI aims to regenerate nerve tissue by using a patient's own muscle grafts to create a biological interface. This method could potentially restore nerve function and reduce pain more effectively. By focusing on nerve regeneration, RPNI presents a promising alternative that could lead to improved outcomes for patients suffering from neuromas.

What evidence suggests that the Peripheral Nerve Regenerative Interface is effective for reducing symptomatic neuroma formation?

Research has shown that the Regenerative Peripheral Nerve Interface (RPNI) effectively reduces pain from neuromas, which are painful nerve growths. In one study with 45 patients who underwent RPNI, none developed neuromas, and only about half experienced phantom limb pain. This method helps nerves reconnect properly, reducing pain. A review of several studies also found that RPNI reduces phantom and residual limb pain more effectively than standard treatments. In this trial, some participants will undergo RPNI during their sural nerve and muscle biopsy, while others will have the biopsy alone. Overall, RPNI surgery can lessen physical pain and improve patients' quality of life. ^{1 3 4 5 6}

Who Is on the Research Team?

Jenna-Lynn Senger, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for individuals who are undergoing sural nerve biopsy due to conditions like neuroma, including Morton's Neuroma. The study aims to see if a special surgical technique called RPNI can prevent painful nerve growths after the biopsy.

Inclusion Criteria

I am 18 or older and referred for a nerve and muscle biopsy at UBC for diagnosis.

Exclusion Criteria

I have had previous nerve damage due to injury, surgery, or multiple biopsies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sural nerve and muscle biopsy, with or without RPNI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for symptomatic neuroma formation and changes in pain and sensation

6 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Peripheral Nerve Regenerative Interface (RPNI)

Trial Overview The trial is testing whether adding a procedure called Regenerative Peripheral Nerve Interface (RPNI) during sural nerve biopsies can reduce the chances of developing symptomatic neuromas compared to just having the biopsy alone.

How Is the Trial Designed?

Group I: Biopsy and RPNI Experimental Treatment 1 Intervention

Patients in this group will undergo RPNI during their sural nerve and muscle biopsy

Group II: Biopsy Alone Active Control 1 Intervention

Patients in this group will only undergo sural nerve and muscle biopsy

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

In a study involving 16 amputees who received regenerative peripheral nerve interfaces (RPNIs) for symptomatic neuromas, patients reported a significant 71% reduction in neuroma pain and a 53% reduction in phantom pain after surgery.

The RPNI procedure demonstrated a favorable safety profile, with 75% of patients expressing satisfaction with the treatment and a high likelihood of recommending it to others, indicating its efficacy as a treatment option for neuroma relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study. Woo, SL., Kung, TA., Brown, DL., et al.[2022]

Prophylactic Regenerative Peripheral Nerve Interface (RPNI) effectively prevents neuroma pain in both male and female rats, indicating its potential as a pain management strategy.

However, the study found that female rats experienced a delay in pain relief compared to males, with specific types of pain (cold and thermal allodynia) being alleviated only in males, suggesting sex-specific differences in pain response and underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexually Dimorphic Pattern of Pain Mitigation Following Prophylactic Regenerative Peripheral Nerve Interface (RPNI) in a Rat Neuroma Model. Dehdashtian, A., Timek, JH., Svientek, SR., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10942837/

Regenerative Peripheral Nerve Interface Surgery for the ... In the same studies that report the efficacy of RPNI surgery for neuroma pain, chronic phantom limb pain (PLP) improved with RPNI surgery as well.

2. neurology.org neurology.org/doi/10.1212/WNL.0000000000211060

A Systematic Review and Meta-analysis (P5-7.001) This meta-analysis demonstrates that TMR and RPNI significantly reduce PLP and RLP compared to standard treatment, enhancing pain management and functional ...

3. frontiersin.org frontiersin.org/journals/molecular-neuroscience/articles/10.3389/fnmol.2022.938930/full

Regenerative Peripheral Nerve Interfaces Effectively ... In the clinical study by Kubiak et al., 45 patients who received RPNI did not develop neuromas and only 51% had phantom limb pain, whereas six ...

4. journals.lww.com journals.lww.com/aosopen/fulltext/2025/03000/regenerative_peripheral_nerve_interface_surgery_to.6.aspx

Regenerative Peripheral Nerve Interface Surgery to Treat... RPNI surgery leverages the processes of reinnervation to successfully treat residual limb pain and improve psychosocial outcomes in patients with chronic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05008185

Regenerative Peripheral Nerve Interfaces to Treat Painful ... This will be a prospective observational study that seeks to provide a comprehensive assessment of the outcomes after RPNI surgery compared to standard of ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667396722000799

Regenerative peripheral nerve interface for the treatment of ... Woo et al demonstrated a 71% reduction in neuroma pain, and a 53% reduction in phantom pain, in 16 amputees (3 upper extremities and 14 lower extremities), ...