Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Unknown

Conditions: Epilepsy, Drug Resistant; Acupuncture Therapy

Treatments: Other: Sham-TEA (STEA); Other: Thread Embedding Acupuncture (TEA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04673071

617/UMP-BOARD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Thread Embedding Acupuncture (TEA)

Active Comparator group

Description:

TEA once a month for 4 months + AEDs

Treatment:

Other: Thread Embedding Acupuncture (TEA)

Sham-TEA (STEA)

Sham Comparator group

Description:

STEA once a month for 4 months + AEDs

Treatment:

Other: Sham-TEA (STEA)