Back to results

Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

Primary Purpose

Epilepsy, Drug Resistant, Acupuncture Therapy

Status

Unknown status

Phase

Not Applicable

Locations

Vietnam

Study Type

Interventional

Intervention

Thread Embedding Acupuncture (TEA)

Sham-TEA (STEA)

About this trial

This is an interventional treatment trial for Epilepsy, Drug Resistant focused on measuring Drug resistant epilepsy, Thread embedding acupuncture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

Nguyen Tri Phuong HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Thread Embedding Acupuncture (TEA)

Sham-TEA (STEA)

Arm Description

TEA once a month for 4 months + AEDs

STEA once a month for 4 months + AEDs

Outcomes

Primary Outcome Measures

Seizure freedom

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

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04673071

First Posted

December 7, 2020

Last Updated

August 24, 2021

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

1. Study Identification

Unique Protocol Identification Number

NCT04673071

Brief Title

Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

Official Title

Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 17, 2020 (Actual)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Drug Resistant, Acupuncture Therapy

Keywords

Drug resistant epilepsy, Thread embedding acupuncture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thread Embedding Acupuncture (TEA)

Arm Type

Active Comparator

Arm Description

TEA once a month for 4 months + AEDs

Arm Title

Sham-TEA (STEA)

Arm Type

Sham Comparator

Arm Description

STEA once a month for 4 months + AEDs

Intervention Type

Other

Intervention Name(s)

Thread Embedding Acupuncture (TEA)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sham-TEA (STEA)

Intervention Description

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 Measure Information:

Title

Seizure freedom

Description

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

Title

Quality of life (QOL)

Description

Time Frame

5 months

Secondary Outcome Measure Information:

Title

Seizure Severity

Description

Time Frame

3 months

Title

Epileptiform discharges

Description

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dan V Nguyen, MD

Phone

+84983731326

nguyenvandan@ump.edu.vn

First Name & Middle Initial & Last Name or Official Title & Degree

Minh-An T Le, MD

Phone

+84903754494

minhanle@ump.edu.vn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan V Nguyen, MD

Organizational Affiliation

University of Medicine and Pharmacy at HCMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nguyen Tri Phuong Hospital

City

Ho Chi Minh City

ZIP/Postal Code

700000

Country

Vietnam

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Minh-An T Le, MD

Phone

+84903754494

minhanle@ump.edu.vn

First Name & Middle Initial & Last Name & Degree

Nguyen

Phone

+84983731326

nguyenvandan@ump.edu.vn

First Name & Middle Initial & Last Name & Degree

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Demographic characteristic and outcome data will be shared

IPD Sharing Time Frame

1 year after the trial finish and for 2 years

Citations:

PubMed Identifier

24801225

Citation

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

Results Reference

background

PubMed Identifier

23662118

Citation

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.

Results Reference

background

PubMed Identifier

30522504

Citation

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.

Results Reference

background

Citation

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

Results Reference

result

PubMed Identifier

10356376

Citation

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.

Results Reference

result

Citation

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.

Results Reference

result

Learn more about this trial

Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

We'll reach out to this number within 24 hrs