Evaluation of the Efficacy and Safety of High-Definition Transcranial Direct Current Stimulation for Pain Reduction in Post-Stroke Pain Patients: Investigator-Initiated, Single-Center, Randomized, Crossover, Single-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of pain score in Brief Pain Inventory(BPI)
研究概览
简要总结
This study aims to assess the effectiveness of multichannel transcranial direct current stimulation (tDCS) in alleviating pain and to evaluate its safety in patients with central post-stroke pain (CPSP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 19 and 90 years.
- •Diagnosed with first-ever stroke based on clinical observation and neuroimaging by a physician.
- •Stroke lesion located in the cortex or subcortex [basal ganglia (BG) or thalamus].
- •Fulfillment of mandatory criteria for pain (pain in the body part corresponding to central nervous system lesions, onset of pain immediately after stroke, confirmation that the pain corresponds to the lesion site, exclusion of other causes of pain such as peripheral neuropathic pain).
- •Cognitive ability sufficient to understand and follow the instructions of the researcher.
- •Voluntary consent to participate in the clinical trial and signed informed consent.
排除标准
- •History of fractures or orthopedic surgeries on the affected side.
- •Presence of significant pre-existing neurogenic disorders.
- •Co-existing severe psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia.
- •Complex regional pain syndrome (CRPS) diagnosed based on Budapest criteria.
- •Other causes of pain in the affected area, such as peripheral nerve damage.
- •Exclusion criteria for transcranial magnetic stimulation (e.g., pregnancy, cancer, patients with abnormal responses to stimulation, presence of intracranial metal implants, hypersensitivity to pain, history of seizures, or injuries/skin conditions at electrode attachment sites).
- •Deemed unsuitable for participation in the study by the principal investigator.
结局指标
主要结局
Change of pain score in Brief Pain Inventory(BPI)
时间窗: Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention)
The Brief Pain Inventory (BPI) is a widely used questionnaire for assessing pain. It measures pain intensity over the past week or the last 24 hours using four 11-point Likert scale items: worst pain, least pain, average pain, and current pain. Additionally, it evaluates how pain interferes with daily activities, mood, walking ability, normal work, relationships with others, sleep, and leisure activities, also using an 11-point Likert scale. The total score ranges from 0 (no pain) to 40 (worst pain), with higher scores indicating greater musculoskeletal pain severity. Pain intensity is categorized as mild (1-4), moderate (5-6), or severe (7-10).
次要结局
- Change of pain score in Neuropathic Pain Scale(NPS)(Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention))
- Change of depression score in Beck Depression Inventory-II(BDI-II)(Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention))
- Change of quality of life score in the EuroQol Five-dimensions-Three-Level Quality of Life Instrument(EQ-5D-3L)(Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention))
- Change in Blood Pressure to Sustained Muscle Contraction(Baseline(prior to the first intervention), Week 2(after the end of the first device intervention), Week 3(prior to the second device intervention), and Week 4(after the end of the second device intervention))
研究者
Yong-il Shin
Professor
Pusan National University Yangsan Hospital