RecruitingNot ApplicableNCT05890508

Electro-acupuncture for Long Covid Neuropsychiatric Symptoms

Electro-acupuncture for Long Covid Neuropsychiatric Symptoms: a Prospective, Randomized Sham-controlled, Double-blinded Clinical Trial

Sponsor

Hong Kong Baptist University

Enrollment

150 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Long Covid19 Neuropsychiatric Symptoms Electro-acupuncture

Summary

In this study, a 16-week randomized, sham-controlled, double-blinded clinical trial will be conducted to to investigate the efficacy and safety of electro-acupuncture compared to sham acupuncture for treatment of long covid neuropsychiatric symptoms.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria7

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.

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Interventions

DEVICEAcupuncture

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.

DEVICESham-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".