NCT06382272招募中不适用
Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Psychophysical tasks to assess stimulation-elicited sensation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mastectomy/Reconstruction
Experimental
Standard treatment our intervention/arm is just the implanting of the device.
干预措施: Bionic Breast implant (Device)
结局指标
主要结局
Psychophysical tasks to assess stimulation-elicited sensation
时间窗: 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.
次要结局
- Maximum stimulation level(7 months after mastectomy+implantation and removal of device)
- Amplitude discrimination task(7 months after mastectomy+implantation and removal of device)
- Magnitude estimation(7 months after mastectomy+implantation and removal of device)
- Projected field mapping(7 months after mastectomy+implantation and removal of device)
- Frequency discrimination task(7 months after mastectomy+implantation and removal of device)
研究者
研究点 (2)
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