Electro-acupuncture for Long Covid Neuropsychiatric Symptoms

NCT05890508 | Recruiting DMC

• 1 other identifier: 2021HMRF
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long Covid19; Neuropsychiatric Symptoms; Electro-acupuncture

Outcome Measures

Primary Outcomes (2)

• Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale

  The MMSE can evaluate of five different domains of cognitive functions: (1) Orientation, with a maximum of 10 points, (2) Memory, with a maximum of 6 points, (3) Attention and calculation, with a maximum of 5 points, (4) Language, with a maximum of 8 points, and (5) Design copying, with a maximum of 1 point. It has a maximum score of 30, with MMSE score denotes severity of cognitive impairment as follows; mild: MMSE 21 to 24, moderate: MMSE 10 to 20, severe: MMSE less than 10.

  At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).

• Depression on the Chinese Beck Depression Inventory (CBDI)

  The scale has a total of 21 questions, with an overall score of 63, 14-19 being mild depression, 20-28 being moderate depression, and above 29 being severe depression.

  At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).

Secondary Outcomes (3)

• Score of Insomnia Severity Index (ISI)

  At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).

• Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form

  At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).

• Score of the Short Form 12 (SF12)

  At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).

Study Arms (2)

Electro-acupuncture group

EXPERIMENTAL

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.

Device: Acupuncture

Sham-acupuncture group

SHAM COMPARATOR

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. .

Device: Sham-acupuncture

Interventions

Acupuncture DEVICE

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.

Electro-acupuncture group

Sham-acupuncture DEVICE

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".

Sham-acupuncture group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Zhong Lidan

Kowloon Tong, Kowloon, 637551, Hong Kong

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Dong Jue Wei, MD

  Hong Kong Baptist University

  STUDY CHAIR

Central Study Contacts

Linda Zhong, MD., Ph.D

CONTACT

852 34116523; ldzhong0305@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All patients and the investigators including the research assessors, the statistician, and the researchers interacting with the patients except the one who conducts the acupuncture therapy will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 6, 2023
• Study Start: March 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

HK (1)