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临床试验/NCT05226676
NCT05226676撤回不适用

Long-term Effects of Repetitive TMS in Chronic Neuropathic Pain in People With SCI

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家开始时间: 2023年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Neuropathic Pain Scale (NPS)

研究概览

简要总结

Around 80% of people with spinal cord injury (SCI) develop chronic neuropathic pain (CNP). This is a debilitating condition with major negative impacts on people's quality of life. Many treatment options have been offered (invasive stimulation, drugs) but provide limited effects and many secondary effects. There is a critical need to develop a new generation of therapies. Transcranial magnetic stimulation (TMS) is a non-invasive and painless brain stimulation technique that allows researchers to explore and change brain excitability that has shown promising effects in neuropathic pain. However there is not enough evidence of what are the long lasting effects of the different protocols. In this study, 30 SCI subjects with CNP in their hands will participate in the study. The objective is to evaluate the efficacy of real versus sham repetitive transcranial magnetic stimulation (rTMS) and investigate 1) short and long term effects on pain and 2) the behavioral and neurophysiological qualities of responders and non-responders to this treatment.This will be a randomized sham controlled trial with two groups: real or sham high frequency repetitive TMS protocol (20Hz). The protocol will be done daily for two weeks. Clinical, functional and neurophysiological evaluations will be assessed at baseline, post intervention and at 6-week follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Neuropathic Pain Scale (NPS)

时间窗: 6 weeks

This scale was developed to assess both the quantitative and qualitative qualities of NP. It includes 11 items, assessing global pain intensity, unpleasantness, and one item which allows the patient to describe the temporal aspects of their pain and its qualities in their own words. The remaining 8 items assess specific NP qualities: "Sharp," "Hot," "Dull," "Cold," "Sensitive," "Itchy," "Deep," and "Surface." This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total scale from 0-10, with higher score indicating more pain.

次要结局

  • The American Spinal Injury Association Impairment Scale (ASIA scale)(6 weeks)
  • Modified Ashworth Scale (MAS)(6 weeks)
  • Numeric Rating Scale (NRS)(6 weeks)
  • Short-Form McGill Pain Questionnaire. (SF-MPQ)(6 weeks)
  • Present Pain Intensity (PPI) index(6 weeks)
  • Visual Analogue Scale (VAS)(6 weeks)
  • Spinal cord independence measure (SCIM III)(6 weeks)
  • Patient's Global Impression of Change (PGIC)(6 weeks)
  • Beck Depression Inventory (BDI)(6 weeks)
  • Resting Motor Threshold (RMT)(6 weeks)
  • Recruitment curve (RC)(6 weeks)
  • Silent period (SP):(6 weeks)
  • Sensory threshold (ST):(6 weeks)
  • Short intracortical inhibition (SICI)(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Del Mar Cortes

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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