Bionic Breast Project: A Neuroprosthesis to Restore Touch Sensation and Reduce Chronic Pain After Mastectomy

项目摘要/摘要 全世界有数百万女性接受了乳房切除和乳房再造手术。简单(也 乳房切除术，乳腺癌女性最常见的乳房切除手术，截肢 所有的乳房组织，包括第三到第六肋间神经，使乳房麻木。损失 感觉是一种令人痛苦的症状(影响超过60%)，它会导致主要的不良反应，包括 受伤的风险增加，身体变形(感觉乳房不再是身体的一部分)，失去触觉- 基于情感的交流(例如，拥抱的感觉)，以及性感的丧失。乳房切除术 也经常导致慢性神经病理性疼痛(25%-60%)，这是一种昂贵和负担沉重的疾病 干预不能可靠地缓解。我们的解决方案，仿生乳房装置(BBD)，结合了神经 刺激方法(成功地应用于肢体截肢者的仿生手脚恢复触摸) 新型组织状可伸展传感器，可检测应用于乳头乳晕复合体的压力。BBD将 触发肋间神经刺激，唤起在原本没有知觉的乳房上感受到的感觉。这个 目前0期试验的目的是首次表征电击的感官后果 在最近接受乳房切除术的女性身上，激活支配乳房的肋间神经。 在这项研究中，我们将在女性乳房切除术中在肋间神经T3和T4上植入袖带电极。 程序。参与者均为接受双侧乳房切除二期同种异体植入物的妇女。 重建早期乳腺癌(单侧原位或T1N0，2 cm)或降低乳腺癌风险。跟随 植入电极的乳房切除术后4-6周的恢复期，参与者将每周接受两次治疗 心理物理测试，在此期间，将通过 经皮导引电极。参与者将在治疗过程中取出电极和经皮引线 他们计划在乳房切除后12-20周进行第二阶段重建手术。这样做的具体目的是 研究内容包括：(1)建立电刺激肋间神经的参数 可感知和可区分的感觉，并表征身体上投射的区域；(2)表征 激活肋间神经引起的感觉的特征，包括其性质和知觉 自然度；以及(3)测量短期(植入期间)和长期(种植后6个月) 间歇性电刺激肋间神经对乳腺癌术后疼痛的影响。这场审判将 确定触觉可以通过神经刺激恢复到乳房。数据也将被获取到 告知未来的可行性(包括安全性)、有效性和可接受性试验。仿生乳房项目提出 以相对较低的成本和风险获得巨大收益，因此具有真正变革性的潜力。

PROJECT SUMMARY/ABSTRACT Millions of women worldwide have undergone mastectomy and breast reconstruction procedures. Simple (also called total) mastectomy, the most common mastectomy procedure for women with breast cancer, amputates all of the breast tissue, including the third through sixth intercostal nerves, leaving the breast numb. Loss of sensation is a distressing symptom (affecting more than 60%) that leads to major adverse effects, including elevated risk of injury, disembodiment (a feeling that the breasts no longer are part of one's body), loss of touch- based affective communication (e.g., the feel of an embrace), and loss of erogenous sensation. Mastectomy also often results in chronic neuropathic pain (25-60%), a costly and burdensome condition that standard interventions cannot reliably alleviate. Our solution, the Bionic Breast Device (BBD), combines a neural stimulation approach (successfully deployed to restore touch in bionic hands and feet in limb amputees) with a novel tissue-like stretchable sensor that detects pressure applied to the nipple-areolar complex. The BBD will trigger stimulation of intercostal nerves, evoking a sensation experienced on the otherwise insensate breast. The objective of the present Phase 0 trial is to characterize, for the first time, the sensory consequences of electrically activating the intercostal nerves that innervate the breast in women who have recently undergone a mastectomy. In this study, we will implant cuff electrodes on intercostal nerves T3 and T4 in women during their mastectomy procedure. Participants will all be women undergoing bilateral mastectomy with two stage alloplastic (implant) reconstruction for early breast cancer (unilateral in situ or T1N0, <2cm) or breast cancer risk reduction. Following a 4-6 week recovery period after mastectomy with electrode implantation, participants will undergo twice-weekly psychophysical testing sessions during which electrical stimulation will be applied to the nerves through the electrodes via percutaneous leads. Participants will have the electrodes and percutaneous leads removed during their planned second stage reconstructive surgery 12-20 weeks after mastectomy. The specific aims of this research are to: (1) Establish the parameters of electrical stimulation of the intercostal nerves that evoke perceptible and distinguishable sensations and characterize the projected fields on the body; (2) Characterize the features of the sensations evoked via activation of the intercostal nerves, including their quality and perceived naturalness; and (3) Gauge the short (during implantation) and longer-term (6 months following explantation) impact of intermittent electrical stimulation of the intercostal nerves on post-mastectomy pain. This trial will establish that 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. The Bionic Breast Project proposes enormous benefit at relatively low cost and risk and thus has the potential to be truly transformative.