Clinical trial NCT05890508: Electro-acupuncture for Long Covid Neuropsychiatric Symptoms
Official title: Electro-acupuncture for Long Covid Neuropsychiatric Symptoms: a Prospective, Randomized Sham-controlled, Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long Covid19
Neuropsychiatric Symptoms
Electro-acupuncture
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive score on the Chinese version of the Mini-Mental State Examination (MMSE) scale
timeFrame: At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).
measure: Depression on the Chinese Beck Depression Inventory (CBDI)
timeFrame: 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:
measure: Score of Insomnia Severity Index (ISI)
timeFrame: At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).
measure: Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form
timeFrame: At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).
measure: Score of the Short Form 12 (SF12)
timeFrame: At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up).
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Zhong Lidan
state: Kowloon
Study officials:
affiliation: Hong Kong Baptist University
name: Dong Jue Wei, MD
role: STUDY_CHAIR
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