Epilepsy, Drug ResistantNCT04673071
Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy
A study testing Thread Embedding Acupuncture (TEA) in people with Epilepsy, Drug Resistant and Acupuncture Therapy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy, Drug Resistant, Acupuncture Therapy
- What is being tested?
- Thread Embedding Acupuncture (TEA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 17 Nov 2020to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People with drug resistant epilepsy
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Nguyen Tri Phuong Hospital
Ho Chi Minh City, 700000
Minh-An T Le, MD, +84903754494, minhanle@ump.edu.vn
Nguyen, +84983731326, nguyenvandan@ump.edu.vn
About this study
Official title: Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy: a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Epilepsy, Drug Resistant, Acupuncture Therapy
- Being tested
- Thread Embedding Acupuncture (TEA), Sham-TEA (STEA)
- Keywords
- Drug resistant epilepsy, Thread embedding acupuncture
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Thread Embedding Acupuncture (TEA) | Active comparator | TEA once a month for 4 months + AEDs Receives: Other: Thread Embedding Acupuncture (TEA) |
| Sham-TEA (STEA) | Sham comparator | STEA once a month for 4 months + AEDs Receives: Other: Sham-TEA (STEA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure freedom
Percentage of seizure reduction in seizure frequency compared to baseline seizure frequency. Seizure frequency is recorded by the participants using seizure diary.
Measured: 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.
Measured: 5 months
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start17 Nov 2020
- Primary completionJul 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, Drug ResistantStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minh-An Thuy Le, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Dan V Nguyen, MD, Principal investigator, University of Medicine and Pharmacy at HCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673071
- Sponsor's protocol ID
- 617/UMP-BOARD
- Status last verified
- Aug 2021
- First submitted
- 7 Dec 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic characteristic and outcome data will be shared
Publications
Cheuk DK, Wong V. Acupuncture for epilepsy. Cochrane Database Syst Rev. 2014 May 7;2014(5):CD005062. doi: 10.1002/14651858.CD005062.pub4.
PubMed 24801225Chao 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.
PubMed 23662118Kim 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.
PubMed 30522504J. 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
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.
PubMed 10356376Da-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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04673071
- Acronym / sponsor ID
- 617/UMP-BOARD
- Conditions
- Epilepsy, Drug Resistant, Acupuncture Therapy
- Keywords
- Drug resistant epilepsy, Thread embedding acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Thread Embedding Acupuncture (TEA) | Active comparator | Other: Thread Embedding Acupuncture (TEA)TEA once a month for 4 months + AEDs |
| Sham-TEA (STEA) | Sham comparator | Other: Sham-TEA (STEA)STEA once a month for 4 months + AEDs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- People with drug resistant epilepsy
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Thread Embedding Acupuncture (TEA) |
| 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. | Other | Sham-TEA (STEA) |
Primary outcome
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.
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.
2 secondary outcomes
Seizure Severity
Time frame: 3 months
Epileptiform discharges
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Background: PubMed 24801225Cheuk DK, Wong V. Acupuncture for epilepsy. Cochrane Database Syst Rev. 2014 May 7;2014(5):CD005062. doi: 10.1002/14651858.CD005062.pub4.
- Background: PubMed 23662118Chao 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.
- Background: PubMed 30522504Kim 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 publicationJ. 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 publication: PubMed 10356376Kloster 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 publicationDa-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.
- Individual participant dataSharing planned: Yes. Demographic characteristic and outcome data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan V Nguyen, MD principal investigator
University of Medicine and Pharmacy at HCMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread Embedding Acupuncture (TEA) in people with Epilepsy, Drug Resistant and Acupuncture Therapy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan V Nguyen, MD (+84983731326, nguyenvandan@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure freedom (time frame: 1 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673071, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.