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Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

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ClinicalTrials.gov Identifier: NCT04673071
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Minh-An Thuy Le, University of Medicine and Pharmacy at Ho Chi Minh City

Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy, Drug Resistant Acupuncture Therapy Other: Thread Embedding Acupuncture (TEA) Other: Sham-TEA (STEA) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy: a Randomized Clinical Trial
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Thread Embedding Acupuncture (TEA)
TEA once a month for 4 months + AEDs
Other: Thread Embedding Acupuncture (TEA)

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 Comparator: Sham-TEA (STEA)
STEA once a month for 4 months + AEDs
Other: Sham-TEA (STEA)
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.




Primary Outcome Measures :
  1. Seizure freedom [ Time Frame: 1 Month ]
    Percentage of seizure reduction in seizure frequency compared to baseline seizure frequency. Seizure frequency is recorded by the participants using seizure diary.

  2. Quality of life (QOL) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Seizure Severity [ Time Frame: 3 months ]
    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.

  2. Epileptiform discharges [ Time Frame: 5 months ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673071


Contacts
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Contact: Dan V Nguyen, MD +84983731326 nguyenvandan@ump.edu.vn
Contact: Minh-An T Le, MD +84903754494 minhanle@ump.edu.vn

Locations
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Vietnam
Nguyen Tri Phuong Hospital Recruiting
Ho Chi Minh City, Vietnam, 700000
Contact: Minh-An T Le, MD    +84903754494    minhanle@ump.edu.vn   
Contact: Nguyen    +84983731326    nguyenvandan@ump.edu.vn   
Principal Investigator: Le         
Sponsors and Collaborators
University of Medicine and Pharmacy at Ho Chi Minh City
Investigators
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Principal Investigator: Dan V Nguyen, MD University of Medicine and Pharmacy at HCMC
Publications of Results:
J. Zhang, Y. Z. Li, and L. X. Zhuang (2006). Observation on therapeutic effect of 90 tonic-clonic epilepsy patients treated by catgut implantation therapy. Zhen Jiu Lin Chuang Za Zhi, vol. 22, no. 6, pp. 8-10, 2006
Da-ke XUAN, Advances of the study on acupoint catgut-embedding for epilepsy in recent 10 years, World Journal of Acupuncture - Moxibustion, Volume 22, Issue 3, 2012, Pages 37-46, ISSN 1003-5257, https://doi.org/10.1016/S1003-5257(12)60039-7.

Other Publications:
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Responsible Party: Minh-An Thuy Le, Lecturer, Principle Investigator, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier: NCT04673071    
Other Study ID Numbers: 617/UMP-BOARD
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Demographic characteristic and outcome data will be shared
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 1 year after the trial finish and for 2 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Minh-An Thuy Le, University of Medicine and Pharmacy at Ho Chi Minh City:
Drug resistant epilepsy
Thread embedding acupuncture
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases