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
基本信息
- 批准号:10753314
- 负责人:
- 金额:$ 84.41万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:Adverse effectsAffectAffectiveAmputeesAnalgesicsBilateralBiomimeticsBionicsBreastBreast Cancer Risk FactorBreast Cancer survivorCase StudyChestCommunicationComplexConsciousCutaneousDataDeafferentation procedureDevelopmentDevicesDistressElectric StimulationElectrodesElectronicsEsthesiaFascicleFeelingFrequenciesFutureGoalsHandHumanImplantImplanted ElectrodesIn SituInjuryInterventionLimb structureLocationMammaplastyMammary Gland ParenchymaMastectomyMeasuresNerveNipplesNumbnessOperative Surgical ProceduresPainParticipantPatientsPhantom Limb PainPhase 0 TrialPhysiologic pulseProbabilityProceduresProcessPsychophysicsQuality of lifeReconstructive Surgical ProceduresRecoveryResearchResidual stateRiskRisk ReductionSafetySensorySignal TransductionSimple mastectomyStructure of radial nerveStructure of ulnar nerveSurgical complicationSymptomsTechnologyTestingTimeTissuesTouch sensationUnited States Food and Drug AdministrationVentral thoracic nerve structureWomanbench to bedsidechronic neuropathic painchronic paincostdesignexperiencefootimplantationimprovedlimb amputationmalignant breast neoplasmmedian nervenerve supplyneural patterningneural stimulationneuroprosthesisnovelpain reductionpressureprimary outcomereconstructionsensorsomatosensorysuccesssurgical risk
项目摘要
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Stacy Tessler Lindau其他文献
Community intervention to reduce cardiovascular disease in Chicago (CIRCL-Chicago): protocol for a type 3 hybrid effectiveness-implementation study using a parallel cluster-randomized trial design
- DOI:
10.1186/s13012-025-01431-w - 发表时间:
2025-05-05 - 期刊:
- 影响因子:13.400
- 作者:
Justin D. Smith;Allison J. Carroll;Yacob G. Tedla;Olutobi A. Sanuade;James L. Merle;Jennifer Heinrich;Jenn Bannon;Emily M. Abramsohn;Faraz S. Ahmad;Danielle Lazar;Stacy Tessler Lindau;Megan C. McHugh;Rasha Khatib;Ramona Donovan;Elizabeth A. Pinkerton;Linda L. Rosul;Theresa L. Walunas;Ricky Watson;Tejashri Ganbote;Namratha Kandula;Quentin R. Youmans;Paris Davis;Abel N. Kho - 通讯作者:
Abel N. Kho
Stacy Tessler Lindau的其他文献
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{{ truncateString('Stacy Tessler Lindau', 18)}}的其他基金
CommunityRx for Hunger - Resubmission 01
CommunityRx for Hunger - 重新提交 01
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9884800 - 财政年份:2019
- 资助金额:
$ 84.41万 - 项目类别:
CommunityRx for Hunger - Resubmission 01
CommunityRx for Hunger - 重新提交 01
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10299620 - 财政年份:2019
- 资助金额:
$ 84.41万 - 项目类别:
CommunityRx for Hunger - Resubmission 01
CommunityRx for Hunger - 重新提交 01
- 批准号:
10079401 - 财政年份:2019
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$ 84.41万 - 项目类别:
CommunityRx for Hunger - Resubmission 01
CommunityRx for Hunger - 重新提交 01
- 批准号:
10526419 - 财政年份:2019
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