Peripheral Nerve Regenerative Interface for Neuroma

(NBxPilot Trial)

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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Peripheral Nerve Regenerative Interface (RPNI) for neuroma?

Early clinical studies and animal models have shown promising results for RPNI in treating and preventing painful neuromas. RPNI works by using a muscle graft to provide a target for nerve growth, which helps prevent the formation of painful nerve endings. ^{1 2 3 4 5}

Is the Regenerative Peripheral Nerve Interface (RPNI) generally safe for humans?

The Regenerative Peripheral Nerve Interface (RPNI) has been studied in both humans and animals, showing that it can prevent neuroma formation and support nerve regeneration without significant safety concerns. In human studies, RPNI has been used to treat postamputation neuroma pain, and in animal studies, it has shown successful nerve integration and muscle graft viability, indicating a favorable safety profile. ^{1 2 4 5 6}

How does the Peripheral Nerve Regenerative Interface treatment differ from other treatments for neuroma?

The Peripheral Nerve Regenerative Interface (RPNI) treatment is unique because it uses a muscle graft to provide a target for nerve growth, preventing painful neuroma formation. Unlike other treatments, RPNI has shown significant improvements in pain management and nerve regeneration by creating a stable biological interface, which is not typically achieved with standard surgical techniques. ^{1 2 4 6 7}

What is the purpose of this trial?

The purpose of our project is to determine if incorporating preventative surgical techniques such as regenerative peripheral nerve interfaces (RPNI) into sural nerve biopsy can reduce the incidence of symptomatic neuroma formation. Findings from this study will inform best practice guidelines and can dramatically impact patient care, improve patient quality of life, and reduce the number of required repeat operations.

Research Team

Jenna-Lynn Senger, MD

Principal Investigator

University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study. [2022]

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

Sexually Dimorphic Pattern of Pain Mitigation Following Prophylactic Regenerative Peripheral Nerve Interface (RPNI) in a Rat Neuroma Model. [2023]

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

Regenerative Peripheral Nerve Interfaces for the Treatment and Prevention of Neuromas and Neuroma Pain. [2022]

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

'Inlay' Regenerative Peripheral Nerve Interface (RPNI) is superior to 'Burrito' RPNI for successful treatment of rat neuroma pain. [2023]

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

Regenerative Peripheral Nerve Interface Surgery: Anatomic and Technical Guide. [2023]

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

Development of a Regenerative Peripheral Nerve Interface for Control of a Neuroprosthetic Limb. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Engineered neuronal microtissue provides exogenous axons for delayed nerve fusion and rapid neuromuscular recovery in rats. [2022]