Modulating Neuropathic Pain With Transcranial Direct Current Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in McGill Pain Questionnaire from baseline 1 and 2 average
研究概览
简要总结
This study will examine whether a form of non-invasive brain stimulation can help reduce pain in people with persistent neuropathic pain.
详细描述
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of three groups by chance. Two groups will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Have chronic (>12 months) neuropathic pain, including but not limited to complex regional pain syndrome, phantom limb pain, or pain of neurogenic origin following spinal cord injury
排除标准
- •History of seizures or epilepsy
- •Addition or change in the dosage of drugs now to interfere with pain within 1 month of enrollment
- •Untreated depression
- •History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
- •Positive pregnancy test or being of childbearing age and not using appropriate contraception
- •Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
研究组 & 干预措施
tDCS of DLPFC
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left dorsolateral prefrontal cortex (DLPFC). Subjects will undergo stimulation once a day for 10 consecutive weekdays.
干预措施: transcranial direct current stimulation (Device)
tDCS of M1
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to the left primary motor cortex (M1). Subjects will undergo stimulation once a day for 10 consecutive weekdays.
干预措施: transcranial direct current stimulation (Device)
Sham tDCS
Subjects will receive 20 minutes of sham transcranial direct current stimulation. Subjects will undergo stimulation once a day for 10 consecutive weekdays.
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
Change in McGill Pain Questionnaire from baseline 1 and 2 average
时间窗: Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention
This self-reported assessment measures intensity and quality of pain. Scores can range from 0 to 45. A decrease in score indicates an improvement in pain.
次要结局
- Change in Short-Form 36 Health Survey from baseline 1 and 2 average(Baseline 1: 1 week before starting intervention, Baseline 2: immediately before starting intervention, Intervention mid-point: after 5 days intervention, Post-intervention: after 10 days intervention, Follow up: 1 month after completing intervention)
研究者
Susan McDowell
Associate Professor
University of Kentucky