Acupuncture for Post COVID-19 Condition (Long COVID) Neuropsychiatric Symptoms

NCT06633666 | Recruiting DMC

• 1 other identifier: 2023Cmdevfund
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, a 12-week pragmatic, randomized, double-blinded clinical trial will be conducted to evaluate the efficacy of acupuncture for the treatment of long Covid neuropsychiatric symptoms and provide reference for clinical non-drug treatment.

Conditions

Long Covid19; Neuropsychiatric Symptom; Acupuncture

Outcome Measures

Primary Outcomes (1)

• 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 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

Secondary Outcomes (6)

• Depression on the Chinese Beck Depression Inventory (CBDI)

  At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

• Score of Insomnia Severity Index (ISI)

  At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

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

  At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

• Hamilton Depression Scale (HAMD)

  At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

• Hamilton Anxiety Rating Scale (HAMA)

  At baseline (before intervention), at 6, 12 weeks (the end of intervention), at 18 weeks (follow-up)

Study Arms (2)

Acupuncture

EXPERIMENTAL

The acupuncture intervention will be conducted for 2 sessions per week during a 12-week treatment duration and will be followed up at week 18. This research is based on the TCM theory of individualized acupuncture. Qualified participants will first conduct TCM syndrome differentiation according to the five main manifestations of Long COVID neuropsychiatric symptoms including fatigue, anxiety/depression, cognitive impairment, memory loss, and insomnia. They will be divided into four treatment groups according to their main clinical symptoms, and the participants in the treatment group will be treated with the selected acupoints according to their disease category. The selection of the acupoints for each syndrome type are formulated with reference to the 13th Five-Year Plan Textbook "Acupuncture and Moxibustion Therapy" published by the China Press of Traditional Chinese Medicine Co.,Ltd.

Device: Acupuncture

Conventional treatment

NO INTERVENTION

The control group will not receive acupuncture therapy. This study does not require the use of a placebo.

Interventions

Acupuncture DEVICE

1. Fatigue Principal points: Pishu (BL 20), Ganshu (BL 18), Shenshu (BL 23), Baihui (GV 20), Guanyuan (RN 4), Zusanli (ST 36), Sanyinjiao (SP 6) 2. Anxiety/ depression Principal points: Yintang (EX-HN3), Baihui (GV 20), Taichong (LR 3), Neiguan (PC 6), Danzhong (RN 7) 3. Cognitive impairment/ memory loss Principal points: Baihui (GV 20), Sishencong (EX-HN1), Fengfu (GV 16), Taixi (K 13), Xuanzhong (GB 39), Zusanli (ST 36) 4. Insomnia Principal points: Zhaohai (K 16), Shenmai (BL 62), Shenmen (HT 7), Sanyinjiao (SP 6), Anmian (EX-HN22), Sishencong (EX-HN1)

Acupuncture

Eligibility Criteria

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

You may qualify if:

• meet the clinical diagnosis of Long COVID by the World Health Organization (WHO), with no neuropsychiatric symptoms 1 year before infection with Covid-19, and continue to have at least one neuropsychiatric symptom for 2 months after SARS-CoV-2 turned negative 3 months above;
• aged 12 to 80 years;
• willing and able to consent, and complete all assessment and study procedures

You may not qualify if:

• patients with a history of chronic neuropsychiatric symptoms;
• cardiovascular diseases pre-existing to the Covid-19 episode such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers;
• documented pre-existing history of psychiatric illness, including substance abuse;
• suicidal tendencies (attempted suicide in the 12 months before the study);
• any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor);
• those who participated in other clinical trials within one month;
• pregnant or lactating female patients;
• have surgery within two months before the study or will have a scheduled surgery during the study;
• acute brain injury or acute encephalopathy from another etiology than Covid-19 (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity);
• open-heart cardiac surgery or cardiac arrest during the last 6 months;
• patients who received acupuncture treatment 1 month before the start of the study;
• patients who were unable to complete the assessment during screening due to severe mental, cognitive, or emotional impairment

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

RECRUITING

Related Publications (15)

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Related Links

• A clinical case definition of post COVID-19 condition

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

85234116523; ldzhong0305@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants will be assigned to the treatment group or the control group according to the ratio of 1:1. This process is carried out by an independent researcher (Research Assistant), and the evaluators and outcome assessor will not know the grouping of the participants until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Associate Professor

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 9, 2024
• Study Start: July 30, 2023
• Primary Completion: January 31, 2026
• Study Completion: April 30, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

HK (1)