Actively Recruiting
Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy
Led by University of Chicago · Updated on 2026-04-27
8
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether touch sensation can be restored to the breast after mastectomy using neural stimulation. This trial aims to gather information to guide future studies on the safety, effectiveness, and acceptability of this approach. The study focuses on women undergoing bilateral mastectomy with two-stage reconstruction for certain types of breast cancer or breast cancer risk reduction. Participants will receive a small medical device called the Bionic Breast implant, temporarily placed in one breast during the mastectomy. This device sends tiny electrical currents to nerves to create sensory stimulation in response to touch or pressure. The device will later be removed, and the study will assess the sensations produced by the stimulation. During the study, participants will complete psychophysical tasks seven months after mastectomy, implantation, and device removal to evaluate sensation and stimulation levels. Researchers will measure outcomes such as stimulation intensity, ability to distinguish different stimuli, and mapping of sensation areas. Participants will be monitored throughout for safety and adherence, with the total study duration spanning several months post-surgery.
CONDITIONS
Brief Title
A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 to T2, clinically, N0 (no lymph node involvement) breast cancer or breast cancer risk reduction due to known elevated breast cancer risk
- 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
You will not qualify if you...
- 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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Device implanted at time of mastectomy and removed within 12 to 20 weeks
Participants undergo mastectomy with the temporary implantation of the Bionic Breast device to restore touch sensation and reduce chronic pain.
Surgery visit plus device removal visit approximately 12 to 20 weeks later
Duration - Up to 7 months after mastectomy and device removal
Participants are monitored after device removal to assess sensory outcomes and pain reduction.
Follow-up visits for psychophysical testing and assessments
Trial Site Locations
Total: 1 location
1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Clinical Trials Intake
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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