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.

项目总结/摘要 全世界有数百万妇女接受了乳房切除术和乳房再造手术。简单（也 称为全）乳房切除术，最常见的乳房切除术程序的妇女与乳腺癌，截肢 所有的乳房组织，包括第三至第六肋间神经，使乳房麻木。损失 感觉是一种令人痛苦的症状（影响超过60%），导致主要的不良反应，包括 受伤的风险增加，脱体（乳房不再是身体的一部分的感觉），失去触摸- 基于情感的通信（例如，拥抱的感觉），以及失去性感的感觉。乳房切除 也经常导致慢性神经性疼痛（25-60%），这是一种昂贵且负担沉重的病症， 干预措施不能可靠地缓解。我们的解决方案，仿生乳房设备（BBD），结合了神经 刺激方法（成功地用于恢复截肢者仿生手和脚的触觉）， 一种新型的组织状可拉伸传感器，可检测施加在乳头乳晕复合体上的压力。BBD将 触发肋间神经的刺激，唤起在其他无感觉的乳房上经历的感觉。的 目前0期试验的目的是首次描述电刺激的感觉后果， 激活支配最近接受乳房切除术的女性乳房的肋间神经。 在这项研究中，我们将植入袖口电极的肋间神经T3和T4的妇女在他们的乳房切除术 procedure.受试者均为接受双侧乳房切除术和两阶段异体（植入）的女性 早期乳腺癌（单侧原位或T1 N 0，<2cm）或乳腺癌风险降低的重建。以下 在乳房切除术和电极植入后4-6周的恢复期，参与者将接受每周两次的 心理物理测试阶段，在此期间，电刺激将通过 通过经皮电极导线。参与者将在手术过程中移除电极和经皮电极导线。 他们计划在乳房切除术后12-20周进行第二阶段重建手术。具体目标是 本研究的目的是：（1）建立肋间神经电刺激参数， 可感知和可区分的感觉，并表征身体上的投影场;（2）表征 通过肋间神经的激活诱发的感觉的特征，包括它们的质量和感知 自然度;和（3）测量短期（植入期间）和长期（植入后6个月） 肋间神经间歇电刺激对乳房切除术后疼痛的影响。本试验将 建立触觉可以通过神经刺激恢复到乳房。还将获得数据， 为未来的可行性（包括安全性）、有效性和可接受性试验提供信息。仿生乳房项目提出 以相对较低的成本和风险获得巨大的收益，因此有可能真正实现变革。