Breast, Chronic Pain, Mastectomy
Conditions
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.
Interventions
DEVICEBionic 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
Sponsors
University of Chicago
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychophysical tasks to assess stimulation-elicited sensation | 7 months after mastectomy+implantation and removal of device | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum stimulation level | 7 months after mastectomy+implantation and removal of device | To determine the maximum range of stimulation that elicits comfortable sensation. |
| Amplitude discrimination task | 7 months after mastectomy+implantation and removal of device | The purpose of this task is to determine the amount by which PA needs to be changed to evoke a reliably distinguishable percept for each C-FINE contact. |
| Frequency discrimination task | 7 months after mastectomy+implantation and removal of device | The purpose of this task is to determine the amount by which pulse frequency (PF) needs to change to evoke a reliably distinguishable percept for each C-FINE contact. |
| Magnitude estimation | 7 months after mastectomy+implantation and removal of device | The purpose of this task is to (further) characterize the relationship between PA/PF and sensory magnitude. |
| Projected field mapping | 7 months after mastectomy+implantation and removal of device | The purpose of this task is to map the location of percepts evoked by stimulation through each C-FINE contact. |
Countries
United States
Contacts
CONTACTClinical Trials Intake
PRINCIPAL_INVESTIGATORStacy Lindau
University of Chicago
Outcome results
None listed