Bionic breast implant to restore touch and reduce chronic pain after mastectomy
Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy
This project will try a bionic breast implant that stimulates nerves to restore touch and reduce chronic pain for adults having bilateral mastectomy with two-stage (tissue expander) reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06382272 on ClinicalTrials.gov |
What this trial studies
Participants will receive a neuroprosthetic bionic breast implant placed during reconstruction after bilateral mastectomy and will have targeted neural stimulation intended to restore touch sensation. The study will collect safety, sensation, pain, and acceptability data during the implant period and through planned removal of the tissue expander 12–20 weeks after implantation. Outcomes will include measures of touch perception, changes in chronic post-mastectomy pain, and participant-reported experience with the device. Data are intended to inform future feasibility, safety, and efficacy trials of this approach.
Who should consider this trial
Good fit: Adults (18+) scheduled for bilateral mastectomy with two-stage tissue-expander reconstruction at the University of Chicago who can speak English or Spanish, have a cell phone for study contact, and do not require adjuvant chemotherapy are ideal candidates.
Not a fit: Patients who need adjuvant chemotherapy, who are having single-stage reconstruction, who have clinical bilateral breast cancer, or who are otherwise poor surgical candidates may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the device could restore some breast sensation and reduce chronic post-mastectomy pain for participants.
How similar studies have performed: Neuroprosthetic approaches have shown promise in restoring sensation or reducing chronic pain in other body areas, but applying a neuroprosthesis to restore breast sensation after mastectomy is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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 T1to T2, clinically, 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 adjuvant chemotherapy * 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
Where this trial is running
Chicago, Illinois
- University of Chicago Medicine Comprehensive Cancer Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Stacy Lindau — University of Chicago
- Study coordinator: Clinical Trials Intake
- Email: cancerclinicaltrials@bsd.uchicago.edu
- Phone: 18557028222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.