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临床试验/NL-OMON45422
NL-OMON45422撤回2 期

The effect of explantation of silicone breast implants on neuroimages of the brain in ASIA-syndrome patients: a pilot fMRI-study<br> - The effect of explantation of SBI on fMRI

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
发起方
入组人数
9

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)

入选标准

  • ASIA-patients (group 1):
  • - Gender: female adults
  • - Age: 25 to 76 years old
  • - Diagnosis of ASIA-syndrome
  • - No diagnosis of a chronic pain syndrome, fibromyalgia (FM) or chronic fatigue syndrome (CFS)).
  • - Silicone filled breast implants
  • - Cosmetic purpose of silicone breast implants
  • - Cognitive impairment and/or memory disturbances;Healthy control patients (group 2):
  • - Gender: female adults
  • - Matched for gender and implant duration
  • - Healthy (no diagnosis of ASIA-syndrome, a chronic pain syndrome, fibromyalgia (FM) or chronic fatigue syndrome (CFS))
  • - Silicone filled breast implants
  • - Cosmetic purpose of silicone breast implants
  • - No complaints of cognitive impairment and/or memory disturbances

排除标准

  • ASIA-patients (group 1):
  • - Pregnancy
  • - Diabetes Mellitus
  • - Claustrophobia or fear of being in a closed space
  • - Neuropathy of the upper or lower extremities
  • - Medication: antidepressants, any analgesics, anticonvulsants, muscle relaxants or benzodiazepines
  • - MRI incompatible health condition (i.e., ICD, pacemaker or other metal prosthetic implants)
  • - Neurological manifestations (CVA/TIA-like complaints);Healthy control patients (group 2):
  • - Pregnancy
  • - Diabetes Mellitus
  • - Medication: antidepressants, any analgesics, anticonvulsants, muscle relaxants or benzodiazepines
  • - MRI incompatible health condition (i.e., ICD, pacemaker or other metal prosthetic implants)
  • - Neurological manifestations (CVA/TIA-like complaints)

研究者

发起方
Medisch Universitair Ziekenhuis Maastricht

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