Nerve Interface Surgery for Pain After Breast Reconstruction

Recruiting at 6 trial locations

Overseen By Babak Mahrara, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Exchange surgery, Active pain, 15 years, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

500 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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Regenerative Peripheral Nerve Interface (RPNI) Surgery for pain management?

Research shows that RPNI surgery has been effective in managing pain and preventing neuroma formation (painful nerve growths) in patients who have had limb amputations. In a study, patients who received RPNI surgery reported no pain, while those who did not have the surgery experienced severe pain. ^{1 2 3 4 5}

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

RPNI surgery has been shown to be a safe technique in clinical studies for treating and preventing neuroma formation in patients with limb amputations, with promising results in both animal and human studies. ^{1 2 3 4 6}

How is the Regenerative Peripheral Nerve Interface (RPNI) treatment different from other treatments for pain after breast reconstruction?

The Regenerative Peripheral Nerve Interface (RPNI) treatment is unique because it uses a small piece of muscle to connect with a cut nerve, helping to prevent painful nerve growths called neuromas. This approach is different from other treatments because it provides a natural target for nerve regrowth, reducing pain and potentially improving the use of prosthetics. ^{2 4 6 7 8}

What is the purpose of this trial?

The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. The study will also look at how effective regenerative peripheral nerve interface (RPNI) surgery is for reducing pain from neuropathic PPMP after breast reconstruction.

Research Team

Danielle Rochlin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This study is for individuals who have undergone a mastectomy and breast reconstruction surgery due to breast cancer and are experiencing persistent pain after the procedures. Specific details on eligibility criteria were not provided.

Inclusion Criteria

I am female.

I have had breast reconstruction using implants or my own tissue.

I have had a mastectomy due to breast cancer or have a genetic risk for it.

Exclusion Criteria

I have not had surgery to replace or fix a medical device within the last 6 months.

I have pain due to an infection, cancer, or a wound.

It has been over 15 years since my reconstruction surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo regenerative peripheral nerve interface (RPNI) surgery to reduce neuropathic pain after breast reconstruction

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Regenerative Peripheral Nerve Interface (RPNI) Surgery

Trial Overview The trial aims to assess how common postmastectomy pain is and evaluate the effectiveness of regenerative peripheral nerve interface (RPNI) surgery in reducing neuropathic pain following breast reconstruction.

Participant Groups

Group I: Postmastectomy Reconstruction Participants Experimental Treatment 4 Interventions

Participants will be postmastectomy reconstruction and \>/= 6 months postoperative

Regenerative Peripheral Nerve Interface (RPNI) Surgery is already approved in United States, European Union for the following indications:

Approved in United States as RPNI Surgery for:

• Post-amputation phantom limb pain
• Neuroma pain
• Post-mastectomy pain syndrome

Approved in European Union as RPNI Surgery for:

• Post-amputation phantom limb pain
• Neuroma pain
• Post-mastectomy pain syndrome

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Regenerative Peripheral Nerve Interfaces (RPNIs) in a rodent model showed that adjacent RPNIs, neurotized by different nerves, can produce independent electromyographic signals during walking, indicating their potential for effective motorized prosthesis control.

The study found that the electromyographic activity from RPNIs was similar to that of control muscles, suggesting minimal crosstalk and confirming that RPNIs can encode distinct neural activation patterns associated with gait.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjacent regenerative peripheral nerve interfaces produce phase-antagonist signals during voluntary walking in rats. Ursu, D., Nedic, A., Urbanchek, M., et al.[2020]

In a study of 28 diabetic amputees, those who underwent regenerative peripheral nerve interface (RPNI) surgery experienced a significant reduction in pain, with all patients in the RPNI group reporting no pain compared to 78.6% of the control group experiencing severe pain.

RPNI not only effectively managed post-amputation pain and reduced the risk of neuroma formation, but it also allowed patients to use prosthetics significantly more, without increasing operative time or complications, suggesting it is a safe and beneficial surgical technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Regenerative Peripheral Nerve Interfaces in Elective Lower Limb Amputations. Pejkova, S., Nikolovska, B., Srbov, B., et al.[2022]

Regenerative peripheral nerve interfaces (RPNIs) successfully recorded myoelectric signals during walking in rats, demonstrating their potential for controlling prosthetic devices with over 80% reliability in predicting ankle motion.

The study showed minimal signal contamination from adjacent muscles, indicating that RPNIs can effectively encode neural activation patterns related to gait, which is crucial for their use in prosthetic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo characterization of regenerative peripheral nerve interface function. Ursu, DC., Urbanchek, MG., Nedic, A., et al.[2017]

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]

In a study using rat models, smaller regenerative peripheral nerve interfaces (RPNIs) constructed with 150 and 300 mg muscle grafts showed significantly better electrical signaling and muscle force compared to larger grafts of 600 and 1200 mg.

Larger RPNIs exhibited areas without regenerated muscle fibers, indicating that smaller grafts are more effective for maintaining tissue viability and enhancing neuroprosthetic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative peripheral nerve interface free muscle graft mass and function. Hu, Y., Ursu, DC., Sohasky, RA., et al.[2021]

The Regenerative Peripheral Nerve Interface (RPNI) is a novel surgical technique that uses an autologous muscle graft to prevent the formation of symptomatic neuromas after limb amputation, addressing a common source of pain and discomfort for amputees.

Clinical and animal studies have shown that RPNI is a safe and effective method for treating and preventing neuroma formation, which can improve outcomes for patients with major limb amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Decreasing Postamputation Pain with the Regenerative Peripheral Nerve Interface (RPNI)". Kubiak, CA., Adidharma, W., Kung, TA., et al.[2022]

In a study of 90 patients, those who received prophylactic regenerative peripheral nerve interfaces during limb amputation had a significantly lower incidence of symptomatic neuromas (0.0%) compared to control patients (13.3%).

Patients with the nerve interfaces also reported much less phantom limb pain (51.1%) compared to control patients (91.1%), indicating that these interfaces may help prevent pain by reducing neuroma formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain. Kubiak, CA., Kemp, SWP., Cederna, PS., 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. England pubmed.ncbi.nlm.nih.gov

Adjacent regenerative peripheral nerve interfaces produce phase-antagonist signals during voluntary walking in rats. [2020]

2. North Macedonia pubmed.ncbi.nlm.nih.gov

Prophylactic Regenerative Peripheral Nerve Interfaces in Elective Lower Limb Amputations. [2022]

3. England pubmed.ncbi.nlm.nih.gov

In vivo characterization of regenerative peripheral nerve interface function. [2017]

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

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

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

Regenerative peripheral nerve interface free muscle graft mass and function. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

"Decreasing Postamputation Pain with the Regenerative Peripheral Nerve Interface (RPNI)". [2022]

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

Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain. [2022]

8. 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]