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

NCT06382272 | Recruiting DMC FDA Device

• 1 other identifier: IRB23-2027
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mastectomy; Breast; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Maximum stimulation level

  7 months after mastectomy+implantation and removal of device

• Amplitude discrimination task

  7 months after mastectomy+implantation and removal of device

• Frequency discrimination task

  7 months after mastectomy+implantation and removal of device

• Magnitude estimation

  7 months after mastectomy+implantation and removal of device

• Projected field mapping

  7 months after mastectomy+implantation and removal of device

Study Arms (1)

Mastectomy/Reconstruction

EXPERIMENTAL

Standard treatment our intervention/arm is just the implanting of the device.

Device: Bionic Breast implant

Interventions

Bionic Breast implant DEVICE

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

Mastectomy/Reconstruction

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stacy Lindau

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Intake

CONTACT

18557028222; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 14, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)