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

The University of Chicago

Status

Enrolling

Conditions

Breast

Mastectomy

Chronic Pain

Treatments

Device: Bionic Breast implant

Study type

Interventional

Funder types

Other

Identifiers

NCT06382272

IRB23-2027

Details and patient eligibility

About

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.

Enrollment

8 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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