Effects of High-definition Transcranial Electrical Stimulation in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline in the Numerical Rating Scale (NRS) after intervention
研究概览
简要总结
Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However, the existing tCES products effect on the whole brain networks and lack special waveforms. The investigators developed a wearable high-definition tCES (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, the investigators will preliminarily examine the effects and safety of the HD-tCES in patients with fibromyalgia. The investigators expect that the HD-tCES will relief pain, improve sleep quality, emotion, and general health of the patients.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a diagnosis of fibromyalgia.
- •Age ≥ 20 years.
- •A mean pain score ≥ 4 on a 11-point numeric rating scale during the 2 weeks preceding the trial.
排除标准
- •Intolerance to electrical stimulation.
- •A history of arrhythmia.
- •Implantable medical electronic devices (e.g., like pacemaker).
- •Metal implants in the head or neck.
- •Wounds on the skin of head.
- •A history of brain surgery or severe brain trauma.
- •Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
- •A history of seizure or other brain pathology.
- •Drug or alcohol abuse.
- •Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
- •Change in medication of fibromyalgia within 1 week prior the trial.
- •Pregnant or breastfeeding women.
- •Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).
- •History of encephalitis or meningitis.
结局指标
主要结局
Change from baseline in the Numerical Rating Scale (NRS) after intervention
时间窗: Baseline (within 7 days ahead to the 1st intervention session), each intervention session in 2 weeks, and after 2-week intervention (within 7 days after the last intervention session)
The NRS is the simplest and most commonly used numeric scale in which the patient rates the pain from 0 (no pain) to 10 (worst pain).
Change from baseline in the Impact Questionnaire (FIQ) after intervention
时间窗: Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session)
The FIQ is a brief 10-item, self-administered instrument that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being.
次要结局
- Change from baseline in the Beck Anxiety Inventory (BAI) after intervention(Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session))
- Change from baseline Tau protein & beta amyloid protein after intervention(Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session))
- Change from baseline pressure pain threshold after intervention(Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session))
- Incidence of treatment-emergent adverse events(Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks))
- Change from baseline in the Beck Depression Inventory Second Edition (BDI-II) after intervention(Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session))
- Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) after intervention(Baseline (within 7 days ahead to the 1st intervention session) and after 2-week intervention (within 7 days after the last intervention session))