Electro-acupuncture for Long Covid Neuropsychiatric Symptoms
NCT ID: NCT05890508
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-03-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Electro-acupuncture group
The electro-acupuncture intervention will be conducted for 2 session per week during 16-week treatment duration, and will be followed up for 8 weeks. In this study, 7 acupoints are chosen:GV20(Baihui), EX-HN1(Sishencong), EX-HN3(Yintang), SP6(Sanyinjiao), ST36(Zusanli), ST40(Fenglong), and LR3(Taichong). The puncture is made in accordance with the standards of traditional Chinese medicine, to a depth of 1 to 3 cm depending on the thickness of the local tissues. The acupoints are subjected to 2-5 Hz electroacupuncture from an electroacupuncture device at an intensity (5 to 10 mA) that can produce a muscle twitch acceptable to the participant.
Acupuncture
Disposable acupuncture needles (0.20 mm in diameter) are are used in the study. The acupoints are GV20(Baihui), EX-HN1(Sishencong), EX-HN3(Yintang), SP6(Sanyinjiao), ST36(Zusanli), ST40(Fenglong), and LR3(Taichong). Electrical stimulation will be delivered with waves at 2-5 Hz from an electroacupuncture device. The needles will be retained in position for 30 minutes.
Sham-acupuncture group
For subjects assigned to the sham control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2/ 0.30 x 30mm) will be applied to serve as a sham control at the corresponding non-acupoints, leave 0.5 cun from the corresponding acupoints, with the same stimulation modality. Addtionally, the stimulation will be a "pseudo stimulation", which will be given by connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument. The credibility and validity of this system have been well demonstrated.
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Sham-acupuncture
Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality and then connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument. The sham points are "pseudo stimulation".
Interventions
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Acupuncture
Disposable acupuncture needles (0.20 mm in diameter) are are used in the study. The acupoints are GV20(Baihui), EX-HN1(Sishencong), EX-HN3(Yintang), SP6(Sanyinjiao), ST36(Zusanli), ST40(Fenglong), and LR3(Taichong). Electrical stimulation will be delivered with waves at 2-5 Hz from an electroacupuncture device. The needles will be retained in position for 30 minutes.
Sham-acupuncture
Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality and then connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument. The sham points are "pseudo stimulation".
Eligibility Criteria
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Inclusion Criteria
* history of SARS-CoV-2 PCR+ at least 4 weeks prior to study entry; SARS-CoV-2 negative (PCR) at study entry;
* at least one persistent neurological symptom (impaired concentration, headache, sensory disturbances, or depression, or "brain fog") that began around the time of the acute COVID-19;
* willing and able to consent, complete all assessment and study procedures.
Exclusion Criteria
* intellectual disability pre-existing to the Covid-19 episode;cardiovascular diseases such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers,
* acute brain injury or acute encephalopathy from another aetiology than covid (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity);
* documented pre-existing history of psychiatric illness, including substance abuse;
* open-heart cardiac surgery or cardiac arrest during the last 6 months;
* current hospitalization;
* pregnant women.
18 Years
80 Years
ALL
No
Sponsors
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Hong Kong Baptist University
OTHER
Responsible Party
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Zhong Lidan
Assistant Professor
Principal Investigators
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Dong Jue Wei, MD
Role: STUDY_CHAIR
Hong Kong Baptist University
Locations
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Zhong Lidan
Kowloon Tong, Kowloon, Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2021HMRF
Identifier Type: -
Identifier Source: org_study_id
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