Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

NCT04673071 | Unknown DMC

• 1 other identifier: 617/UMP-BOARD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Drug Resistant; Acupuncture Therapy

Keywords

Drug resistant epilepsy; Thread embedding acupuncture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Seizure Severity

  3 months

• Epileptiform discharges

  5 months

Study Arms (2)

Thread Embedding Acupuncture (TEA)

ACTIVE COMPARATOR

TEA once a month for 4 months + AEDs

Other: Thread Embedding Acupuncture (TEA)

Sham-TEA (STEA)

SHAM COMPARATOR

STEA once a month for 4 months + AEDs

Other: Sham-TEA (STEA)

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

Thread Embedding Acupuncture (TEA)

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.

Sham-TEA (STEA)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Nguyen Tri Phuong Hospital

Ho Chi Minh City, 700000, Vietnam

RECRUITING

Related Publications (6)

• Cheuk DK, Wong V. Acupuncture for epilepsy. Cochrane Database Syst Rev. 2014 May 7;2014(5):CD005062. doi: 10.1002/14651858.CD005062.pub4.

  PMID: 24801225 BACKGROUND

• Chao D, Shen X, Xia Y. From Acupuncture to Interaction between delta-Opioid Receptors and Na (+) Channels: A Potential Pathway to Inhibit Epileptic Hyperexcitability. Evid Based Complement Alternat Med. 2013;2013:216016. doi: 10.1155/2013/216016. Epub 2013 Apr 3.

  PMID: 23662118 BACKGROUND

• Kim E, Kim HS, Jung SY, Han CH, Kim YI. Efficacy and safety of polydioxanone thread embedded at specific acupoints for non-specific chronic neck pain: a study protocol for a randomized, subject-assessor-blinded, sham-controlled pilot trial. Trials. 2018 Dec 6;19(1):672. doi: 10.1186/s13063-018-3058-9.

  PMID: 30522504 BACKGROUND

• 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

  RESULT

• Kloster R, Larsson PG, Lossius R, Nakken KO, Dahl R, Xiu-Ling X, Wen-Xin Z, Kinge E, Edna Rossberg. The effect of acupuncture in chronic intractable epilepsy. Seizure. 1999 May;8(3):170-4. doi: 10.1053/seiz.1999.0278.

  PMID: 10356376 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dan V Nguyen, MD

  University of Medicine and Pharmacy at HCMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan V Nguyen, MD

CONTACT

+84983731326; nguyenvandan@ump.edu.vn

Minh-An T Le, MD

CONTACT

+84903754494; minhanle@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Principle Investigator

Model Details: 2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 17, 2020
• Study Start: November 17, 2020
• Primary Completion: July 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 year after the trial finish and for 2 years

Locations

VN (1)