In this study, a 16-week randomized, sham-controlled, double-blinded clinical trial willbe conducted to to investigate the efficacy and safety of electro-acupuncture compared tosham acupuncture for treatment of long covid neuropsychiatric symptoms.
This is a prospective, randomized, sham-controlled, double-blinded and multiple center
trial on electro-acupuncture for treating neuropsychiatric symptoms in long covid
patients. A total of 150 participants will be randomly assigned to the
electro-acupuncture and the sham-control group with 1:1 ratio. Both groups will receive
32 sessions of interventions during 16-week treatment duration (2 session per week), and
will be followed up for 8 weeks.
Device: 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.
Device: 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".
Inclusion Criteria:
- adults over 18 years of age to 80;
- 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:
- any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy,
tumor);
- 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.
Zhong Lidan
Kowloon Tong, Kowloon, Hong Kong
Investigator: Zhong Lidan, Ph.D, MD
Contact: 34116523
ldzhong0305@gmail.com
Linda Zhong, MD., Ph.D
852 34116523
ldzhong0305@gmail.com
Dong Jue Wei, MD, Study Chair
Hong Kong Baptist University