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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
8
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
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
RECRUITINGPsychophysical 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 device
Maximum stimulation level
To determine the maximum range of stimulation that elicits comfortable sensation.
Time frame: 7 months after mastectomy+implantation and removal of device
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 device
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 device
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 device
Projected field mapping
The purpose of this task is to map the location of percepts evoked by stimulation through each C-FINE contact.
Time frame: 7 months after mastectomy+implantation and removal of device
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