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.

项目概要/摘要 全世界有数百万女性接受了乳房切除术和乳房重建手术。简单（也 称为全乳房切除术，是乳腺癌女性最常见的乳房切除术，截肢 所有乳房组织，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%），会导致重大不良反应，包括 受伤、脱离身体（感觉乳房不再是身体的一部分）、失去触觉的风险增加 基于情感交流（例如拥抱的感觉），以及性快感的丧失。乳房切除术 还经常导致慢性神经性疼痛（25-60%），这是一种昂贵且繁重的疾病，标准 干预措施不能可靠地缓解。我们的解决方案，仿生乳房装置 (BBD)，结合了神经 刺激方法（成功用于恢复肢体截肢者仿生手脚的触觉） 新型组织状可拉伸传感器，可检测施加到乳头乳晕复合体的压力。 BBD 将 触发肋间神经的刺激，唤起原本无知觉的乳房的感觉。这 目前第 0 阶段试验的目标是首次表征电的感官后果 激活最近接受乳房切除术的女性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期间在肋间神经 T3 和 T4 上植入袖带电极 程序。参与者均为接受两期异体（植入）双侧乳房切除术的女性 早期乳腺癌（单侧原位或 T1N0，<2cm）重建或降低乳腺癌风险。下列的 乳房切除术并植入电极后有 4-6 周的恢复期，参与者将每周接受两次 心理物理测试过程中，电刺激将通过 通过经皮导线的电极。参与者将在实验期间移除电极和经皮导线 他们计划在乳房切除术后 12-20 周进行第二阶段重建手术。本次活动的具体目标 研究目的是：（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射场； (2) 表征 通过肋间神经激活引起的感觉的特征，包括它们的质量和感知 自然性； (3) 评估短期（植入期间）和长期（移植后 6 个月） 间歇性电刺激肋间神经对乳房切除术后疼痛的影响。此次审判将 确定可以通过神经刺激恢复乳房的触觉。数据还将被获取到 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，因此具有真正变革的潜力。