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

仿生乳房项目：神经假体可恢复触觉并减轻乳房切除术后的慢性疼痛

• 批准号: 10753314
• 负责人: Stacy Tessler Lindau
• 金额: $ 84.41万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10753314
• 关键词: Adverse effects; Affect; Affective; Amputees; Analgesics; Bilateral; Biomimetics; Bionics; Breast; Breast Cancer Risk Factor; Breast Cancer survivor; Case Study; Chest; Communication; Complex; Conscious; Cutaneous; Data; Deafferentation procedure; Development; Devices; Distress; Electric Stimulation; Electrodes; Electronics; Esthesia; Fascicle; Feeling; Frequencies; Future; Goals; Hand; Human; Implant; Implanted Electrodes; In Situ; Injury; Intervention; Limb structure; Location; Mammaplasty; Mammary Gland Parenchyma; Mastectomy; Measures; Nerve; Nipples; Numbness; Operative Surgical Procedures; Pain; Participant; Patients; Phantom Limb Pain; Phase 0 Trial; Physiologic pulse; Probability; Procedures; Process; Psychophysics; Quality of life; Reconstructive Surgical Procedures; Recovery; Research; Residual state; Risk; Risk Reduction; Safety; Sensory; Signal Transduction; Simple mastectomy; Structure of radial nerve; Structure of ulnar nerve; Surgical complication; Symptoms; Technology; Testing; Time; Tissues; Touch sensation; United States Food and Drug Administration; Ventral thoracic nerve structure; Woman; bench to bedside; chronic neuropathic pain; chronic pain; cost; design; experience; foot; implantation; improved; limb amputation; malignant breast neoplasm; median nerve; nerve supply; neural patterning; neural stimulation; neuroprosthesis; novel; pain reduction; pressure; primary outcome; reconstruction; sensor; somatosensory; success; surgical risk

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.

项目摘要/摘要 全球数百万妇女进行了乳房切除术和乳房重建程序。简单（也是 称为乳腺癌女性最常见的乳房切除术程序，称为全部）乳房切除术 所有的乳腺组织，包括第三到第六个肋间神经，使乳房麻木。损失 感觉是一种令人痛苦的症状（影响超过60％），导致重大不良影响，包括 受伤的风险升高，没有偏见（乳房不再是人体的一部分），失去触摸 - 基于情感交流（例如，拥抱的感觉）和感性的丧失。乳房切除术 通常还会导致慢性神经性疼痛（25-60％），这是一种标准的昂贵且繁重的疾病 干预措施无法可靠地减轻。我们的解决方案，仿生乳房装置（BBD），结合了神经 刺激方法（成功部署以恢复仿生手和脚脚的触摸） 新型组织样的可拉伸传感器检测到施加到乳头 - 荧光复合物的压力。 BBD会 触发刺激肋间神经，引起对原本不敏感的乳房经历的感觉。这 本阶段0试验的目的是首次表征电气的感觉后果 激活最近接受乳房切除术的女性的乳房的骨间神经。 在这项研究中，我们将在乳房切除术期间将袖口电极植入女性T3和T4上 程序。参与者都将是接受双侧乳房切除术和两阶段同种塑料（植入物）的女性 早期乳腺癌（单侧原位或T1N0，<2cm）或乳腺癌风险降低的重建。下列的 与电极植入乳房切除术后4-6周的恢复期，参与者将每周两次接受两次 心理物理测试会话，在此期间将对神经进行电刺激。 通过经皮引线电极。参与者将在期间删除电极和经皮引线 乳房切除术后12-20周，他们计划的第二阶段重建手术。这个特定的目的 研究是：（1）建立引起肋间神经的电刺激的参数 可感知且可区分的感觉，并表征身体上的投影场； （2）表征 通过激活肋间神经引起的感觉的特征，包括它们的质量和感知 自然（3）衡量短期（植入期间）和长期（露天后6个月） 间歇性电刺激对肋间神经对术后疼痛的影响。这个审判将 确定可以通过神经刺激将触摸感恢复到乳房。数据也将获得 告知未来的可行性（包括安全性），功效和可接受性试验。仿生乳房项目提出 在相对较低的成本和风险下，巨大的收益有可能真正变革。