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

Recruiting now · Not applicable

Conditions studied: Mastectomy, Breast, Chronic Pain

In brief

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.

Key facts

Study ID

NCT06382272

Run by

University of Chicago

People needed

8

Starts

2025-05-14

Expected to finish

2028-01-31

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• University of Chicago Medicine Comprehensive Cancer Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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