Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Seizure freedom
研究概览
简要总结
Epilepsy is one of the most common neurological diseases all over the world. Currently, about 70 million people have epilepsy worldwide. In particular, more than 30% of epilepsy patients still have seizures even though they are treated with appropriate anti-epileptic drugs (AEDs). This number has remained unchanged even after more than 20 years with many new anti-epileptic drugs being introduced. According to International League Against Epilepsy (ILAE), drug-resistant epilepsy is defined when a patient does not achieve seizure-free the seizure with two optimal antiepileptic drugs. This clinical trial is designed to evaluate the effectiveness and safety of thread-embedding acupuncture (TEA) as palliative treatment of drug resistant epilepsy.
详细描述
The objectives of this clinical trial are twofold: the effectiveness of TEA is assessed by comparing the changes in the seizure control and quality of life at 5 months between 2 groups: the TEA + baseline AEDs group and the sham-TEA (STEA) + baseline AEDs group. Adverse events (AEs) that occur during the study will be investigated to evaluate the safety of TEA.
This study is investigated by the following hypotheses:
- TEA can increase the probability of becoming seizure free.
- TEA can reduce the frequency and duration of seizures.
- TEA can improve quality of life.
- TEA is associated with adverse effects.
This clinical trial will be performed as a 2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with drug resistant epilepsy
- •Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
排除标准
- •Under epilepsy surgery
- •Inappropriate condition for thread-embedding acupuncture due to skin disease (the skin of the acupuncture point is swollen, hot, and red) or hemostatic disorder (PT INR (international normalized ratio )> 2.0 or taking anticoagulant)
- •Pregnant women or other inappropriate condition for thread-embedding acupuncture
- •Other diseases that could affect or interfere with therapeutic outcomes, including body exhaustion, severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder
- •TEA within 6 months previous
- •Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
- •Heavy drinking (more than 3 cups per day)
研究组 & 干预措施
Thread Embedding Acupuncture (TEA)
TEA once a month for 4 months + AEDs
干预措施: Thread Embedding Acupuncture (TEA) (Other)
Sham-TEA (STEA)
STEA once a month for 4 months + AEDs
干预措施: Sham-TEA (STEA) (Other)
结局指标
主要结局
Seizure freedom
时间窗: 1 Month
Percentage of seizure reduction in seizure frequency compared to baseline seizure frequency. Seizure frequency is recorded by the participants using seizure diary.
Quality of life (QOL)
时间窗: 5 months
Quality of life was recorded by QOLIE-31 (Quality of Life in Epilepsy) questionnaire The Quality of Life in Epilepsy Inventory (QOLIE-31) contains seven multi-item scales that tap the following health concepts: emotional well-being, social functioning, energy/fatigue, cognitive functioning, seizure worry, medication effects, and overall quality of life. The scoring procedure for the QOLIE-31 first converts the raw coded numeric values of items to 0-100 point scores, with higher converted scores always reflecting better quality of life.
次要结局
- Epileptiform discharges(5 months)
- Seizure Severity(3 months)
研究者
Minh-An Thuy Le
Lecturer, Principle Investigator
University of Medicine and Pharmacy at Ho Chi Minh City