A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy
Recruiting
N/AInterventional Study
MastectomyBreastChronic Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Supportive Care
Participants needed
8 (estimated)
Sponsor
University of Chicago · Other
Who this trial is looking for
This trial is looking for women who are scheduled for a specific type of breast surgery called bilateral mastectomy. Participants will explore if a device can help restore feeling in the breast after surgery and be involved in follow-up through texts and calls.
Are You a Good Fit for This Trial?
Rules you outComplex regional pain syndromeUncontrolled infection
You may be able to join if
I am 18 years old or older
I am scheduled for bilateral mastectomy with reconstruction
I have breast cancer risk factors or early-stage breast cancer
I agree to have the breast tissue expander removed within 12-20 weeks
I can provide my cell phone number and receive texts about the study
I speak and understand English or Spanish
I can participate in the informed consent process
You may not be able to join if
I need adjuvant chemotherapy
I have evidence of bilateral breast cancer
I have had prior breast surgery
I have had radiation in my chest area
I have a pacemaker or similar device
I have a history of uncontrolled diabetes
I am pregnant or planning to become pregnant
I have an untreated mental health condition that poses risks
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 …
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
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