Long-Term Treatment of Patients Experiencing Phantom Limb Pain With Transcranial Direct Current Stimulation (tDCS)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Reduced phantom limb pain
研究概览
简要总结
- Phantom limb pain (PLP) refers to pain in a limb that has been amputated or deafferented. Phantom limb pain might be related to brain cortical plastic changes.
- The purpose of this study is to determine the efficacy of a series of transcranial direct current stimulation (tDCS) sessions, a non-invasive and focal brain stimulation method, in producing long-term reduction of phantom limb pain among amputees who experience such pain.
This is a Crossover sham control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80
- •Limb amputation from at least 6 months before study enrollment
- •Presence of PLP at least 2 times a week and present 4 weeks prior to onset of study
- •Written informed consent
排除标准
- •Coexistence of major neurological or psychiatric diseases
- •Being actively enrolled in a separate study targeting pain relief
- •Post traumatic stress disorder (PTSD) diagnosed patients
- •Any contraindication to noninvasive brain stimulation such as past brain surgery, brain implants, cochlear implant, epilepsy or any past seizure
- •Pregnant women
- •Within the traumatic amputees group - subjects diagnosed with diabetes
研究组 & 干预措施
Crossover 1a: anodal stimulation of M1 + sham
6 amputees will undergo 8 active treatments of 20 min 2mA anodal stimulation of M1 localized to the contralateral amputation area followed by 8 sham treatments.
Total duration and frequency of treatments: 8 weeks, 2 sessions per week.
Each session will last approximately one hour which will consist of:
- EEG and pain measurements
- 20 minutes of stimulation
- EEG and pain measurements after completion of stimulation
干预措施: Anodal stimulation of M1 + sham (Device)
Crossover 1b: sham + anodal stimulation of M1
6 amputees will undergo 8 sham treatments followed by 8 active treatments of 20 min 2mA anodal stimulation of M1 localized to the contralateral amputation area.
Total duration and frequency of treatments: 8 weeks, 2 sessions per week.
Each session will last approximately one hour which will consist of:
- EEG and pain measurements
- 20 minutes of stimulation
- EEG and pain measurements after completion of stimulation
干预措施: Sham + Anodal stimulation of M1 (Device)
Crossover 2a: cathodal stimulation of M1 + sham
6 amputees will undergo 8 active treatments of 20 min 2mA cathodal stimulation of M1 localized to the contralateral amputation area followed by 8 sham treatments.
Total duration and frequency of treatments: 8 weeks, 2 sessions per week.
Each session will last approximately one hour which will consist of:
- EEG and pain measurements
- 20 minutes of stimulation
- EEG and pain measurements after completion of stimulation
干预措施: Cathodal stimulation of M1 + sham (Device)
Crossover 2b: sham + cathodal stimulation of M1
6 amputees will undergo 8 sham treatments followed by 8 active treatments of 20 min 2mA cathodal stimulation of M1 localized to the contralateral amputation area.
Total duration and frequency of treatments: 8 weeks, 2 sessions per week.
Each session will last approximately one hour which will consist of:
- EEG and pain measurements
- 20 minutes of stimulation
- EEG and pain measurements after completion of stimulation
干预措施: Sham + Cathodal stimulation of M1 (Device)
结局指标
主要结局
Reduced phantom limb pain
时间窗: 5 months after last stimulation session
Reduction of phantom limb pain compared to phantom limb pain before treatment, according to Visual Analog Scales (VAS) evaluation
次要结局
- Adverse effects of treatment(Up to 5 weeks)
- Effects of treatment on the electrical activity of the brain(Up to 5 weeks)
研究者
Dr. Itzhak Siev-Ner
Head of The Department of Orthopedic Rehabilitation
Sheba Medical Center