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

Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Mastectomy; Breast
• Intervention / Treatment: Device: Bionic Breast implant

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Intake; Phone Number: 18557028222; Email: cancerclinicaltrials@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medicine Comprehensive Cancer Center
      • Contact: Clinical Trials Intake; Phone Number: 18557028222; Email: cancerclinicaltrials@bsd.uchicago.edu
      • Contact: Bionic Breast Team; Phone Number: (773) 873-2011
      • Principal Investigator: Stacy Lindau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mastectomy/Reconstruction; Standard treatment our intervention/arm is just the implanting of the device.	Device: Bionic Breast implant; A small medical device will be temporarily implanted in one of the breasts at the time of the mastectomy. This device is capable of sending very small electrical currents to the nerves that can deliver sensory stimulation in response to touch and pressure applied to the breast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychophysical tasks to assess stimulation-elicited sensation	The purpose of the detection task is to determine the minimum pulse amplitude (PA) required to elicit a detectable percept for each C-FINE contact.	7 months after mastectomy+implantation and removal of device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum stimulation level	To determine the maximum range of stimulation that elicits comfortable sensation.	7 months after mastectomy+implantation and removal of device
Amplitude discrimination task	The purpose of this task is to determine the amount by which PA needs to be changed to evoke a reliably distinguishable percept for each C-FINE contact.	7 months after mastectomy+implantation and removal of device
Frequency discrimination task	The purpose of this task is to determine the amount by which pulse frequency (PF) needs to change to evoke a reliably distinguishable percept for each C-FINE contact.	7 months after mastectomy+implantation and removal of device
Magnitude estimation	The purpose of this task is to (further) characterize the relationship between PA/PF and sensory magnitude.	7 months after mastectomy+implantation and removal of device
Projected field mapping	The purpose of this task is to map the location of percepts evoked by stimulation through each C-FINE contact.	7 months after mastectomy+implantation and removal of device

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stacy Lindau, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: IRB23-2027; 5R01CA281301 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes