Recruiting

Neural Stimulation

Sponsor:

University of Chicago

Code:

NCT06382272

Conditions

Mastectomy

Breast

Chronic Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bionic Breast implant

Study Details

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

Study ID

NCT06382272

Start date

May 14, 2025

Status verified date

Apr, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Mastectomy/Reconstruction

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

Interventions

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

Primary outcome measure

  • Psychophysical tasks to assess stimulation-elicited sensation [ Time Frame: 7 months after mastectomy+implantation and removal of device ]

Central Contacts and Locations

Central contacts

Clinical Trials Intake

18557028222cancerclinicaltrials@bsd.uchicago.edu

Locations

University of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

18557028222cancerclinicaltrials@bsd.uchicago.edu

Bionic Breast Team

(773) 873-2011

Principal Investigator:

Stacy Lindau

More Information

Sponsor

University of Chicago

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-27.