NCT01575002已完成不适用
Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study.
Spaulding Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Changes in pain scales
研究概览
简要总结
In this study the investigators aim to examine the effects of Transcranial Direct Current Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing in individuals with chronic pain of the cornea -- and also compared with healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •(for all subjects):
- •Provide informed consent to participate in the study;
- •18 to 65 years old;
- •Additional Inclusion Criteria for Subjects with Chronic Corneal Pain:
- •Corneal pain for six months or more;
- •Referral from a corneal specialist (Dr. Perry Rosenthal) with refractoriness to conventional ophthalmologic treatments for corneal pain such as local topical medications and soft bandage contact lenses;
- •Report a Visual Analogue Scale (VAS) for pain of 4 or greater in the previous 3 weeks;
排除标准
- •(for all subjects):
- •History of alcohol or substance abuse within the last 6 months as self-reported;
- •Diagnosis of any neurological diseases (such as epilepsy);
- •Episodes of seizures within the last 6 months;
- •Unexplained loss of consciousness
- •Use of carbamazepine or neuropsychotropic drugs
- •Contraindications to tDCS
- •Metal in the head
- •Implanted brain medical devices
- •Pregnant at time of enrollment
结局指标
主要结局
Changes in pain scales
时间窗: Measured for approximately 2 weeks
We will measure changes in the visual analogue scale (VAS) for pain, and also measure pain threshold (using an algometer) before and after each stimulation session. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS.
次要结局
- Changes in EEG measurements(Measured for approximately 2 weeks)
研究者
Felipe Fregni
Associate Professor
Spaulding Rehabilitation Hospital
研究点 (2)
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