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

> **NIH NIH R01** · UNIVERSITY OF CHICAGO · 2024 · $751,066

## Abstract

PROJECT SUMMARY/ABSTRACT
Millions of women worldwide have undergone mastectomy and breast reconstruction procedures. Simple (also
called total) mastectomy, the most common mastectomy procedure for women with breast cancer, amputates
all of the breast tissue, including the third through sixth intercostal nerves, leaving the breast numb. Loss of
sensation is a distressing symptom (affecting more than 60%) that leads to major adverse effects, including
elevated risk of injury, disembodiment (a feeling that the breasts no longer are part of one's body), loss of touch-
based affective communication (e.g., the feel of an embrace), and loss of erogenous sensation. Mastectomy
also often results in chronic neuropathic pain (25-60%), a costly and burdensome condition that standard
interventions cannot reliably alleviate. Our solution, the Bionic Breast Device (BBD), combines a neural
stimulation approach (successfully deployed to restore touch in bionic hands and feet in limb amputees) with a
novel tissue-like stretchable sensor that detects pressure applied to the nipple-areolar complex. The BBD will
trigger stimulation of intercostal nerves, evoking a sensation experienced on the otherwise insensate breast. The
objective of the present Phase 0 trial is to characterize, for the first time, the sensory consequences of electrically
activating the intercostal nerves that innervate the breast in women who have recently undergone a mastectomy.
In this study, we will implant cuff electrodes on intercostal nerves T3 and T4 in women during their mastectomy
procedure. Participants will all be women undergoing bilateral mastectomy with two stage alloplastic (implant)
reconstruction for early breast cancer (unilateral in situ or T1N0, <2cm) or breast cancer risk reduction. Following
a 4-6 week recovery period after mastectomy with electrode implantation, participants will undergo twice-weekly
psychophysical testing sessions during which electrical stimulation will be applied to the nerves through the
electrodes via percutaneous leads. Participants will have the electrodes and percutaneous leads removed during
their planned second stage reconstructive surgery 12-20 weeks after mastectomy. The specific aims of this
research are to: (1) Establish the parameters of electrical stimulation of the intercostal nerves that evoke
perceptible and distinguishable sensations and characterize the projected fields on the body; (2) Characterize
the features of the sensations evoked via activation of the intercostal nerves, including their quality and perceived
naturalness; and (3) Gauge the short (during implantation) and longer-term (6 months following explantation)
impact of intermittent electrical stimulation of the intercostal nerves on post-mastectomy pain. This trial will
establish that 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. The Bionic...

## Key facts

- **NIH application ID:** 10894812
- **Project number:** 5R01CA281301-02
- **Recipient organization:** UNIVERSITY OF CHICAGO
- **Principal Investigator:** Stacy Tessler Lindau
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $751,066
- **Award type:** 5
- **Project period:** 2023-08-01 → 2028-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10894812

## Citation

> US National Institutes of Health, RePORTER application 10894812, Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy (5R01CA281301-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10894812. Licensed CC0.

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