A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Requires adjuvant chemotherapy
Single stage mastectomy and reconstruction procedure
Clinical evidence of bilateral breast cancer
Clinical evidence of lymph node involvement
Trial design
Design model
Single group
Treatments tested in this trial
Bionic Breast implant
DeviceA 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
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: Mastectomy/ReconstructionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Psychophysical tasks to assess stimulation-elicited sensation
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.
Time frame
7 months after mastectomy+implantation and removal of deviceSecondary outcomes
1
Maximum stimulation level
To determine the maximum range of stimulation that elicits comfortable sensation.
Time frame
7 months after mastectomy+implantation and removal of device2
Amplitude discrimination task
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.
Time frame
7 months after mastectomy+implantation and removal of device3
Frequency discrimination task
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.
Time frame
7 months after mastectomy+implantation and removal of device4
Magnitude estimation
The purpose of this task is to (further) characterize the relationship between PA/PF and sensory magnitude.
Time frame
7 months after mastectomy+implantation and removal of deviceSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov