A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy
Trial Parameters
Brief Summary
This trial seeks to establish whether or not touch sensation can be restored to the breast via neural stimulation. Data will also be obtained to inform future feasibility (including safety), efficacy, and acceptability trials.
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