Menu
Recruiting NCT06382272

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

No phase Interventional Mastectomy Breast Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bionic Breast implant.
Who it may be relevant to
Registry conditions: Mastectomy, Breast, Chronic Pain. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Psychophysical tasks to assess stimulation-elicited sensation [Time frame: 7 months after mastectomy+implantation and removal of device]
Secondary outcome measures (5)
  • Maximum stimulation level [Time frame: 7 months after mastectomy+implantation and removal of device]
  • Amplitude discrimination task [Time frame: 7 months after mastectomy+implantation and removal of device]
  • Frequency discrimination task [Time frame: 7 months after mastectomy+implantation and removal of device]
  • Magnitude estimation [Time frame: 7 months after mastectomy+implantation and removal of device]
  • Projected field mapping [Time frame: 7 months after mastectomy+implantation and removal of device]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Chicago Medicine Comprehensive Cancer Center — Chicago

Identifiers

NCT: NCT06382272 · IRB23-2027 · 5R01CA281301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗