Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04673071 |
Recruitment Status : Unknown
Verified August 2021 by Minh-An Thuy Le, University of Medicine and Pharmacy at Ho Chi Minh City.
Recruitment status was: Recruiting
First Posted : December 17, 2020
Last Update Posted : August 26, 2021
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy, Drug Resistant Acupuncture Therapy | Other: Thread Embedding Acupuncture (TEA) Other: Sham-TEA (STEA) | Not Applicable |
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 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 |
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. |
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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
Contact: Dan V Nguyen, MD | +84983731326 | nguyenvandan@ump.edu.vn | |
Contact: Minh-An T Le, MD | +84903754494 | minhanle@ump.edu.vn |
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 |
Principal Investigator: | Dan V Nguyen, MD | University of Medicine and Pharmacy at HCMC |
Other Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Drug resistant epilepsy Thread embedding acupuncture |
Epilepsy Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |