Nerve Interface for Post-Mastectomy Pain

Overseen By Research Administrator

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: George Kokosis

Disqualifiers: Chronic pain syndrome, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

200 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the study team.

What data supports the effectiveness of the treatment Regenerative Peripheral Nerve Interface for post-mastectomy pain?

Research shows that Regenerative Peripheral Nerve Interfaces can prevent and treat pain after limb amputations by stopping painful nerve growths (neuromas) and reducing phantom limb pain. This suggests they might also help with post-mastectomy pain by addressing similar nerve-related issues. ^{1 2 3 4 5}

Is the regenerative peripheral nerve interface safe for humans?

Studies on regenerative peripheral nerve interfaces, including those with implanted electrodes, have shown that they are generally safe, with no significant presence of inflammation or tissue damage in animal models. This suggests they may be safe for human use, but more research is needed to confirm this. ^{1 2 4 6 7}

How does the Regenerative Peripheral Nerve Interface treatment differ from other treatments for post-mastectomy pain?

The Regenerative Peripheral Nerve Interface (RPNI) is unique because it involves an implanted interface that connects nerves to external electronics, potentially providing sensory feedback and improving nerve function. This approach is different from traditional pain management methods, as it aims to restore nerve function and communication rather than just alleviating pain. ^{2 5 8 9 10}

What is the purpose of this trial?

Regenerative peripheral nerve interface (RPNI) was first developed in 2012 by Dr. Paul Cederna at the University of Michigan as a means for amputees to control their prothesis with their minds. In the decade that followed, it was found RPNI surgery not only provided amputees with neuroma (a growth made up nerve tissue) pain relief but could help prevent neuroma from developing as well. This single center, randomized controlled, investigator-initiated study will look at whether the RPNI, a nerve burying procedure involving protecting sensory nerves with a small piece of the patient's pectoralis muscle, performed at the time of the standard mastectomy with immediate breast reconstruction surgery can prevent and/or reduce the risk for long-term nerve pain after breast cancer surgery (also called neuroma-related post-breast surgery pain syndrome (PBSPS)) versus the standard surgery alone (Control group). Symptoms of PBSPS include discomfort, numbness, tingling, and shooting pain in the chest and breast area. It is relatively common and may have many causes. About 200 adult females (18-65 years old) who are scheduled to undergo mastectomy with immediate breast reconstruction surgery will be approached for this study. Those who agree and sign the informed consent form will be randomized in 1:1 fashion (50/50 chance) to either the RPNI group or the no RPNI (Control) group. Study participants will complete self-reported surveys (pre-surgery and at Months 1, 3, 6, and 12 post-surgery) designed to measure pain levels, quality of life, and function before and after surgery. Study participation will last approximately 12 months. Subjects will remain blinded to their assigned study arm until their study participation has concluded.

Research Team

George Kokosis, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for adult females aged 18-65 who are planning to have a mastectomy with immediate breast reconstruction. Participants must be willing to complete surveys about their pain and quality of life before and after surgery.

Inclusion Criteria

Able to provide informed consent and comply with study procedures

I am a woman aged between 18 and 65.

I am having a breast removal with immediate reconstruction.

Exclusion Criteria

Cognitive impairment or language barriers preventing proper understanding of study procedures and assessments

Unwillingness or inability to comply with the study's follow-up requirements

I have a long-term pain condition not related to breast surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mastectomy with immediate breast reconstruction surgery, with or without the RPNI procedure

1 day

1 visit (in-person)

Follow-up

Participants complete self-reported surveys at Months 1, 3, 6, and 12 post-surgery to measure pain levels, quality of life, and function

12 months

4 visits (virtual)

Treatment Details

Interventions

• Regenerative Peripheral Nerve Interface

Trial Overview The study tests if the RPNI procedure, which involves protecting nerves with muscle tissue during mastectomy, can prevent or reduce long-term nerve pain compared to standard surgery. Patients will be randomly assigned to either receive RPNI or not.

Participant Groups

Group I: RPNI Experimental Treatment 1 Intervention

Subjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects will in the RPNI arm will undergo mastectomy with breast reconstruction surgery with regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records.

Group II: No RPNI (Control) Active Control 1 Intervention

Subjects will complete BREAST-Q Pre-Op (Qol) survey and Pain Distribution survey prior to Surgery. Subjects undergo mastectomy with breast reconstruction surgery without regenerative peripheral nerve interface. Subjects will complete BREAST-Q Post-Op (QoL) survey and Pain Distribution Survey at Months 1, 3, 6, and 12 post-surgery. Information about the patient and course of care will be collected from electronic medical records.

Who Is Running the Clinical Trial?

George Kokosis

Lead Sponsor

Trials

1

Recruited

200+

Findings from Research

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]

The study assessed the biocompatibility of the transverse intrafascicular multi-channel electrode (TIME) by implanting it in the median nerves of Göttingen minipigs for 33-38 days, showing no significant inflammatory response or necrosis, indicating good safety.

The presence of only a layer of fibrosis around the implant suggests that the TIME could be a promising neural interface for future use in neuroprostheses, as it demonstrates favorable biosafety characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biosafety assessment of an intra-neural electrode (TIME) following sub-chronic implantation in the median nerve of Göttingen minipigs. Kundu, A., Wirenfeldt, M., Harreby, KR., et al.[2017]

References

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

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

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

Regenerative peripheral nerve interface viability and signal transduction with an implanted electrode. [2022]

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

Restoration of Proprioceptive and Cutaneous Sensation Using Regenerative Peripheral Nerve Interfaces in Humans with Upper Limb Amputations. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Ultrasound appearance of regenerative peripheral nerve interface with clinical correlation. [2023]

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

Characterizing sensory thresholds and intensity sensitivity of Regenerative Peripheral Nerve Interfaces: A Case Study. [2022]

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

Biosafety assessment of an intra-neural electrode (TIME) following sub-chronic implantation in the median nerve of Göttingen minipigs. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Nerve guidance conduit development for primary treatment of peripheral nerve transection injuries: A commercial perspective. [2021]

8. Japan pubmed.ncbi.nlm.nih.gov

Facilitatory effects of artificial nerve filled with adipose-derived stem cell sheets on peripheral nerve regeneration: An experimental study. [2021]

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

A regenerative microchannel neural interface for recording from and stimulating peripheral axons in vivo. [2022]

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

Regenerative Electrode Interfaces for Neural Prostheses. [2016]