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
|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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
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, MDfirstname.lastname@example.org|
|Contact: Minh-An T Le, MDemail@example.com|
|Principal Investigator:||Dan V Nguyen, MD||University of Medicine and Pharmacy at HCMC|