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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA281301 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mastectomy/Reconstruction | Experimental | Standard treatment our intervention/arm is just the implanting of the device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bionic Breast implant | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 months after mastectomy+implantation and removal of device |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum stimulation level | To determine the maximum range of stimulation that elicits comfortable sensation. | 7 months after mastectomy+implantation and removal of device |
| Amplitude discrimination task |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Intake | Contact | 18557028222 | cancerclinicaltrials@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stacy Lindau | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine Comprehensive Cancer Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| 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. | 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. | 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. | 7 months after mastectomy+implantation and removal of device |