Electro-acupuncture for Long Covid Neuropsychiatric Symptoms

Hong Kong Baptist University

Status: Enrolling

Conditions: Long Covid19; Neuropsychiatric Symptoms; Electro-acupuncture

Treatments: Device: Sham-acupuncture; Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05890508

2021HMRF

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Electro-acupuncture group

Experimental group

Description:

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.

Treatment:

Device: Acupuncture

Sham-acupuncture group

Sham Comparator group

Description:

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. .

Treatment:

Device: Sham-acupuncture