Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

Last updated: August 24, 2021
Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT04673071
617/UMP-BOARD
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • People with drug resistant epilepsy
  • Volunteers who agree to participate and sign the Informed Consent Form, following adetailed explanation of clinical trials

Exclusion

Exclusion Criteria:

  • Under epilepsy surgery
  • Inappropriate condition for thread-embedding acupuncture due to skin disease (the skinof 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, includingbody 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 orschizophrenia
  • Heavy drinking (more than 3 cups per day)

Study Design

Total Participants: 60
Study Start date:
November 17, 2020
Estimated Completion Date:
November 30, 2022

Study 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.

Connect with a study center

  • Nguyen Tri Phuong Hospital

    Ho Chi Minh City, 700000
    Vietnam

    Active - Recruiting

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