Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

University of Medicine and Pharmacy at Ho Chi Minh City60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Epilepsy, Drug Resistant

Interventions

Thread Embedding Acupuncture (TEA)OTHER

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

Sham-TEA (STEA)OTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Seizure freedom

Percentage of seizure reduction in seizure frequency compared to baseline seizure frequency. Seizure frequency is recorded by the participants using seizure diary.

Time frame: 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.

Time frame: 5 months

Secondary Outcomes

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.

Time frame: 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.