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临床试验/NCT05545358
NCT05545358尚未招募不适用

Experimental Study of the Neural Bases of Phantom Pain After Amputation and Their Modification by Proprioceptive Training: MRI Study of the Brain and Spinal Cord

Direction Centrale du Service de Santé des Armées0 个研究点目标入组 75 人开始时间: 2022年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
主要终点
Change in brain activity, measured through fMRI, following proprioceptive training

研究概览

简要总结

The amputation of a limb results in chronic pain associated with the lost limb in the majority of patients, which persists over time. Despite a large number of studies conducted in an attempt to elucidate the neural basis of phantom pain, these are still not elucidated and current treatments often fail to relieve patients' pain.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 18 and 65 years old
  • For the "amputees with phantom pain" group: patients who have been amputated for more than 2 years and have chronic phantom pain
  • For the "amputees without phantom pain" group: patients who have been amputated for more than 2 years and do not have chronic phantom pain
  • For the "healthy participants" group: healthy participants with no neurological history

排除标准

  • Clinically significant pathology (gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory)
  • Progressive psychiatric or neurological pathology
  • On psychotropic medication
  • Pregnant or nursing woman
  • Inadequate level of French language

结局指标

主要结局

Change in brain activity, measured through fMRI, following proprioceptive training

时间窗: Up to 3 months

Brain activity (BOLD hemodynamic response) will be measured via fMRI before and after proprioceptive training sessions.

Change in spinal cord activity, measured through spinal fMRI, following proprioceptive training

时间窗: Up to 3 months

Spinal cord activity (BOLD hemodynamic response) will be measured via spinal fMRI before and after proprioceptive training sessions.

次要结局

未报告次要终点

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

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