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

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.
项目总结/文摘

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
  • 批准号:
    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:
    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
  • 批准号:
    10079401
  • 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:
    10526419
  • 财政年份:
    2019
  • 资助金额:
    $ 84.41万
  • 项目类别:
Evaluating a Self-Care Innovation for Older Adults using Agent-Based Modeling
使用基于代理的建模评估老年人的自我护理创新
  • 批准号:
    8748691
  • 财政年份:
    2014
  • 资助金额:
    $ 84.41万
  • 项目类别:
Evaluating a Self-Care Innovation for Older Adults using Agent-Based Modeling
使用基于代理的建模评估老年人的自我护理创新
  • 批准号:
    9293944
  • 财政年份:
    2014
  • 资助金额:
    $ 84.41万
  • 项目类别:
Evaluating a Self-Care Innovation for Older Adults using Agent-Based Modeling
使用基于代理的建模评估老年人的自我护理创新
  • 批准号:
    9108807
  • 财政年份:
    2014
  • 资助金额:
    $ 84.41万
  • 项目类别:
Evaluating a Self-Care Innovation for Older Adults using Agent-Based Modeling
使用基于代理的建模评估老年人的自我护理创新
  • 批准号:
    9309663
  • 财政年份:
    2014
  • 资助金额:
    $ 84.41万
  • 项目类别:
Evaluating a Self-Care Innovation for Older Adults using Agent-Based Modeling
使用基于代理的建模评估老年人的自我护理创新
  • 批准号:
    8918401
  • 财政年份:
    2014
  • 资助金额:
    $ 84.41万
  • 项目类别:
Sexuality, Aging and Heart Disease: Translating from Population to Patient
性、衰老和心脏病:从人群到患者的转变
  • 批准号:
    7731711
  • 财政年份:
    2009
  • 资助金额:
    $ 84.41万
  • 项目类别:

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社交媒体上的情感病毒传播:文化和理想情感的作用
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