Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy: a Randomized Clinical Trial

Conditions
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Epilepsy, Drug Resistant, Acupuncture Therapy

Intervention / Treatment
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* Other: Thread Embedding Acupuncture (TEA)
* Other: Sham-TEA (STEA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with drug resistant epilepsy Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thread Embedding Acupuncture (TEA)<br>TEA once a month for 4 months + AEDs | Other: Thread Embedding Acupuncture (TEA)<br>* TEA in 1 month for 4 months The six TEA points used in this study are GV20, BL15, BL18, ST40, GV14 and GB34. Acupuncture point Procedure Baihui (GV20) oblique insertion toward nose, 3cm Both Xin Shu (BL15) perpendicular insertion, 3cm Both Gan Shu (BL18) perpendicular insertion, 3cm Both Fenglong (ST40) perpendicular insertion, 3cm Dazhui (GV14) perpendicular insertion, 3cm Both Yanglingquan (GB34) perpendicular insertion, 3cm<br>|
| Sham Comparator: Sham-TEA (STEA)<br>STEA once a month for 4 months + AEDs | Other: Sham-TEA (STEA)<br>* STEA in 1 month for 4 months All procedure of Sham-TEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure freedom | Percentage of seizure reduction in seizure frequency compared to baseline seizure frequency. Seizure frequency is recorded by the participants using seizure diary. | 1 Month | 
| Quality of life (QOL) | 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. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure Severity | The National Hospital Seizure Severity Scale (NHS3) was recorded The scale is administered by a health professional during an interview with a patient and a witness to the seizures. It contains seven seizure-related factors and generates a score from 1 to 27. The higher score reflects the more severity of seizure. | 3 months | 
| Epileptiform discharges | Epileptiform discharges (ED) were recorded in Electroencephalograph (EEG). Epileptiform discharges are defined as generalized or focal polyspikes, polyspike-wave, spike-wave, sharp and sharp - wave occurring in the forms of a single discharge or a burst. The duration of discharges are from 20 - 200 milliseconds. The EDs are interpreted and numbers of ED are counted during a standard EEG by trained neurologists. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug resistant epilepsy, Thread embedding acupuncture