A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy

Launched by UNIVERSITY OF CHICAGO · Apr 19, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help women who have had both breasts removed (a surgery called bilateral mastectomy) to reduce long-lasting pain and bring back the sense of touch in the breast area. The study uses a special device called a neuroprosthesis, which sends gentle electrical signals to nerves, with the goal of restoring feeling after surgery. This trial is currently looking for women aged 18 and older who are scheduled to have this type of breast surgery and reconstruction at the University of Chicago Medicine.

If you join the study, you will have the neuroprosthesis device implanted during your two-stage breast reconstruction. The study team will collect information to see if this device is safe, if it helps restore touch, and whether patients find it acceptable. You’ll also be asked to share your phone number and receive text messages as part of the study check-ins. It’s important to know that some women won’t be eligible, such as those needing radiation after surgery, having certain medical conditions, or who have implants like pacemakers. The study team will carefully review medical history and may ask for a psychological evaluation to make sure the trial is right for you. Overall, this study aims to improve quality of life for women after mastectomy by addressing pain and sensation in a new and hopeful way.

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• • 18 years of age or older
• • Scheduled for bilateral mastectomy with two-stage (tissue expander) reconstruction at UCM
• • Bilateral mastectomy for unilateral in situ or T1 (\<2 cm), N0 (no lymph node involvement) breast cancer or breast cancer risk reduction due to known elevated breast cancer risk. (Note - 19-34% of women choosing mastectomy for small unilateral breast cancer elect bilateral mastectomy.)40 We will enroll from this cohort.
• • Agrees to have breast tissue expander removed within 12-20 weeks of implantation.
• • Has access to a cell phone and willing to provide the research interviewer with the cell phone number
• • Agrees to receive text messages from the study
• • Able to speak and understand English or Spanish
• • Able to participate in the informed consent process
• Exclusion criteria:
• • Requires breast radiation
• • Single stage mastectomy and reconstruction procedure
• • Clinical evidence of bilateral breast cancer
• • Clinical evidence of lymph node involvement
• • Prior history of mastectomy or other major breast surgery
• • Prior history of radiation to the chest area (e.g., mantle radiation for Hodgkin's disease)
• • Prior history of injury (e.g., trauma, surgery, burn) that the participant perceives to have had an effect on the sensation of the breast
• • Pregnant or intending to become pregnant during the study period
• • Pacemaker, defibrillator or other implanted electrical stimulation device that may be affected by the implanted electrodes
• • Complex regional pain syndrome or other pain syndromes or a history of a neurologic condition like multiple sclerosis, degenerative neurological disease, cognitive impairment or dementia
• • Uncontrolled diabetes
• • History of poor wound healing or chronic skin ulcerations
• • History of uncontrolled infection or active infection at time of consent
• • Expectation that MRI will be required while the devices are implanted
• • Inability or unwillingness to follow verbal instructions and comply with study procedures
• • Untreated or poorly managed physical or mental health condition that may pose additional risk according to clinical judgment of the patient's breast surgeon or surgeons
• • Unwillingness to undergo psychological evaluation to determine study eligibility, if requested or required by surgeons or investigators