Long Covid19 Clinical Trial
Official title:
Electro-acupuncture for Long Covid Neuropsychiatric Symptoms: a Prospective, Randomized Sham-controlled, Double-blinded Clinical Trial
| NCT number | NCT05890508 |
| Other study ID # | 2021HMRF |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 1, 2024 |
| Est. completion date | April 30, 2026 |
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | April 30, 2026 |
| Est. primary completion date | January 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Zhong Lidan | Kowloon Tong | Kowloon |
| Lead Sponsor | Collaborator |
|---|---|
| Hong Kong Baptist University |
Hong Kong,
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* Note: There are 28 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | |
| Primary | 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 | Score of Insomnia Severity Index (ISI) | The Insomnia Severity Index in Chinese includes 5 questions to assess the severity and impact of insomnia, on an 0 to 4 scale, with the higher score reflecting worse insomnia symptoms. | 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 | Score of Brief Fatigue Inventory-Taiwanese (BFI-T) Form | BFI-T form is to assess the severity of fatigue and the impact of fatigue on daily functioning. Scoring Respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10). | At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up). | |
| Secondary | Score of the Short Form 12 (SF12) | The SF-12V2 is a widely used generic HRQoL instrument, and its Chinese version has been validated and normed in the general Chinese population in Hong Kong. It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The scores are generated using an algorithm to generate a combined physical and mental health score for comparison with normative data. In the normative data: 1) the mean score was set to 50; 2) a score > 50 indicated better physical or mental health than the mean; 3) a score < 50 indicated worse physical or mental health than the mean. | At baseline (before intervention), at 4, 8, 12, 16 weeks (the end of intervention) and 2 months after intervention (the end of follow-up). |