跳至主要内容
临床试验/NCT03702556
NCT03702556已完成不适用

The Representation of the Breast on the Somatosensory Cortex After Autologous Breast Reconstruction Using 7 Tesla Functional MRI.

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
The neuroplasticity of the brain after breast reconstruction

研究概览

简要总结

Rationale: To study the effects of mastectomy and autologous breast reconstruction on the sensation of the (reconstructed) breast, not only the peripheral reinnervation of the breast should be studied, but also the changes that take place in the somatosensory cortex. Now that the region of interest in the brain and the somatotopy of the non-operated breast are known, studies with patients who underwent mastectomy and breast reconstruction are the next step to understand the neuroplasticity of the brain following breast surgery.

Objective: To study the neuroplasticity of the brain after mastectomy and breast reconstructive surgery by assessing the somatotopy of the breast on the somatosensory cortex of patients who underwent either breast reconstruction with and without nerve restoration or mastectomy without breast reconstruction.

Study design: A single center imaging study carried out in Maastricht University Medical Center.

Study population: A total of 30 female breast cancer patients who underwent a unilateral mastectomy without breast reconstruction or a mastectomy followed by a unilateral autologous breast reconstruction with a deep inferior epigastric artery perforator (DIEP) flap will be included in this study. Three groups of patients will be selected and compared: ten patients who underwent a mastectomy without breast reconstruction, ten patients who underwent a DIEP flap breast reconstruction with sensory nerve restoration of the flap and ten patients who underwent a DIEP flap without nerve restoration.

Intervention: Every subject will undergo a single functional MRI scan in a 7 Tesla MRI scan at least six months after the operation. A scanning session takes approximately 75 minutes. During the scan, piezo-electric stimulators are applied to both the reconstructed and non-operated breast in a fixed pattern. These stimulators stimulate the skin and sensory nerves of the breast and nipple-areola complex in a random sequence.

Main study parameters: The hemodynamic response after stimulation of the skin of the breast and nipple-areola complex, representing neuronal activity in that region, is measured. Within the somatosensory cortex (S1 and S2), the temporo-spatial brain activity patterns after the various stimulation conditions are assessed, and the representation of the breast on the somatosensory cortex is mapped.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female over 18 years old
  • Unilateral mastectomy without breast reconstruction
  • Unilateral mastectomy with DIEP flap breast reconstruction (with or without sensory nerve restoration)
  • At least six months after the operation
  • Informed consent

排除标准

  • Bilateral mastectomy / breast reconstruction
  • Previous surgery, disease or treatment of the contralateral breast
  • Active disease / metastasis
  • Previous radiation therapy on the chest or axilla
  • Diseases associated with neuropathy (e.g. diabetes mellitus)
  • Previous brain surgery
  • Previous allergic reactions to adhesives or plasters
  • Any MRI exclusion criteria:
  • No piercings or other iron materials (except a metal brace behind front teeth)
  • Claustrophobia

结局指标

主要结局

The neuroplasticity of the brain after breast reconstruction

时间窗: 75 minutes

Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex will be measured. Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.

次要结局

  • Differences in the somatotopy between patients who underwent a breast reconstruction with nerve restoration compared to patients who underwent breast reconstruction without nerve restoration.(75 minutes)
  • Differences in the somatotopy between patients who underwent mastectomy without breast reconstruction compared to patients who underwent breast reconstruction.(75 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验