NCT01112774终止不适用
Investigation of the Mechanisms of Transcranial Direct Current Stimulation of Motor Cortex for the Treatment of Chronic Pain in Spinal Cord Injury
Spaulding Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Neurophysiological activity changes after treatment with tDCS
研究概览
简要总结
The purpose of this study is to determine whether the novel treatment of transcranial direct current stimulation (tDCS) could decrease the pain perception of those with spinal cord injury.
We will also determine whether these changes are correlated with the clinical outcome (pain reduction).
详细描述
The active tDCS stimulation sessions will be compared to sham stimulation.
More study details will be provided by Spaulding Rehabilitation Hospital.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •STUDY ELIGIBILITY CRITERIA (similar to the criteria of the Interstitial Cystitis Network)
- •Providing informed consent to participate in the study
- •18 to 64 years old
- •with traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)
- •stable chronic pain for at least the three preceding months(for spinal cord injury only)
- •score higher or equal to 4cm (0 cm= 'no pain' and 10cm='worst possible pain') on the Visual Analogue Scale (VAS) for pain perception at the baseline/start of the treatment(for spinal cord injury only)
- •refractoriness to drugs for pain relieve - such as tricyclic antidepressants, antiepileptic drugs and/or narcotics (pain resistant to at least 2 of these drugs supplied in adequate dosages for six months) (for spinal cord injury only)
- •pain is not attributable to other causes, such as peripheral inflammation.
- •No clinically significant or unstable medical or psychiatric disorder
- •No history of substance abuse
- •No neuropsychiatric comorbidity
- •No implanted devices for pain control, such as vagal or deep brain stimulators
- •No contraindications to tDCS:
- •metal in the head
- •implanted brain medical devices
- •No pregnancy
- •Eligible to MRI according to MRI screening checklist.
- •No use of ventilators
排除标准
- 未提供
结局指标
主要结局
Neurophysiological activity changes after treatment with tDCS
时间窗: baseline, 2 weeks treatment and follow up (2 weeks)
Magnetic resonance spectroscopy (MRS), electroencephalogram (EEG), transcranial magnetic stimulation (TMS)
次要结局
- Pain changes(Baseline, 2 weeks treatment and follow up (2 weeks))
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital
研究点 (2)
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