Transcranial Stimulation (TDCS) For The Treatment of Neuropathic Facial Pain.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Primary outcome will be a composite measure "Pain intensity/consumption of pain medication".
研究概览
简要总结
A study to determine if transcranial direct current stimulation (tDCS, the device that regulates brain activity, can improve pain in people with neuropathic facial pain and compare which modality (inhibitory tDCS over the somatosensory cortex or excitatory tDCS over the motor cortex) can result in better pain-relief.)
详细描述
This is a pilot study designed to collect preliminary data on safety and efficacy of transcranial direct current stimulation (tDCS)to relieve pain in subjects with neuropathic facial pain,and to compare two pain-treatment tDCS modalities: inhibitory tDCS stimulation over the somatosensory cortex and excitatory tDCS over the motor cortex.
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, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Spontaneous facial neuropathic pain due to any of following:
- •Trigeminal neuralgia, type 1, (TN1): facial pain of spontaneous onset with predominantly episodic pain.
- •Trigeminal neuralgia, type 2, (TN2): facial pain of spontaneous onset with predominantly constant pain.
- •Trigeminal neuropathic pain, (TNP): facial pain resulting from unintentional injury to the trigeminal system from facial trauma, oral surgery, ear, nose and throat (ENT) surgery, root injury from posterior fossa or skull base surgery, stroke, etc.
- •Trigeminal deafferentation pain, (TDP): facial pain in a region of trigeminal numbness resulting from intentional injury to the trigeminal system from neurectomy, gangliolysis, rhizotomy, nucleotomy, tractotomy, or other denervating procedures.
- •Symptomatic trigeminal neuralgia, (STN): facial pain resulting from multiple sclerosis.
- •e) Postherpetic neuralgia, (PHN): facial pain resulting from trigeminal Herpes zoster (shingles) outbreak in the trigeminal distribution.
- •Pain intensity score for "worst pain in the last 24 hours" >4 on a numeric scale 0-10 at the time of enrollment and before the first stimulation of each treatment block.
- •Pain intensity score for "pain right now" >4 on a numeric scale 0-10 before the first stimulation of each block of treatment.
排除标准
- •Uncontrolled hypertension, uncontrolled diabetes, uncontrolled cardiovascular disease
- •Other painful conditions than neuropathic facial pain, that are not related to and can't be distinguished from the neuropathic facial pain
- •Pregnancy
- •Implanted neurostimulation devices (e.g. a spinal cord stimulator, a deep brain stimulator, etc)
- •Active illegal drug/alcohol abuse
- •Unable to follow directions or complete tools in English.
结局指标
主要结局
Primary outcome will be a composite measure "Pain intensity/consumption of pain medication".
时间窗: Daily from Baseline to up to 17 weeks
The washout period between phase I and phase II of the study is variable as patients have to go back to their baseline.
次要结局
未报告次要终点