Efficacy of Acupuncture in Patients Post-Covid Brain Fog

Study Overview
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Brief Summary
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After being infected with Covid-19, many people developed to Brain fog. The treatment strategy now is based on the presumed pathological phenomenon and the physician's clinical experience. Acupuncture has been used to improve cognitive dysfunction caused by central nervous system diseases for many years. A randomized rater-blinded controlled study is proposed to see the efficacy of acupuncture for brain fog.

Detailed Description
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After being infected with Covid-19, many people develop cognitive dysfunction, including deficits in attention, executive ability, language, processing speed, and memory. These symptoms are collectively known as Brain fog or Covid fog. The pathological mechanism of the cognitive deficit is inconclusive. Therefore, the treatment strategy is based on the presumed pathological phenomenon and the physician's clinical experience. Acupuncture has been used to improve cognitive dysfunction caused by central nervous system diseases for many years. This study aims to evaluate the medium and long-term clinical efficacy of acupuncture in patients with post-Covid related Mild cognitive impairment (MCI). A randomized rater-blinded controlled study is proposed. Eligible patients were over 18 years old and <65 years old. These patients were diagnosed with Covid-19 more than 12 weeks earlier and developed mild cognitive impairment (MCI) after the diagnosis of Covid-19. Divided into the acupuncture group and the sham acupuncture group for an 8-week course of treatment, the Mini-Mental State Examination (MMSE), the quality of life assessment scale The 5-level EQ(EuroQol Group)- five dimensions version(EQ-5D-5L) and The Stroop Color and Word Test evaluates the degree of cognitive impairment and the impact of cognitive impairment on quality of life and attention.

Official Title
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The Objective of Our Study is to Evaluate the Medium and Long-term Clinical Efficacy of Acupuncture in Patients With Post Covid Related Mild Cognitive Impairment (MCI).

Conditions
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Brain Fog

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been tested positive for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) or had serum antibody positivity more than 12 weeks before. Present cognitive impairment after been diagnosed as Covid-19 Clinical Dementia Rating (CDR) score of 1 Normal activities of daily living score (ADL) (Mini-Mental State Examination) MMSE score of 24-28 Age of 18-65 years Signed informed consent Exclusion Criteria: Diagnosed with any type of dementia. A history of acute or chronic cerebrovascular disease, encephalitis, Parkinson's disease, Leukoencephalopathy, and other central nervous system diseases A history of hypothyroidism, vitamin B12 deficiency, depression, syphilis, and other diseases that may affect cognitive decline. Severe hearing and visual impairment, inability to complete neuropsychological tests Impaired liver and kidney function and hematopoietic system disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Practicing acupuncture on specific acupoints. The retention time of the needle is 30 minutes every time and the frequency of treatment is 3 times per week for 8 weeks. | Other: Acupuncture<br>* Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.<br>|
| Sham Comparator: Placebo group<br>Practicing sham acupuncture on specific acupoints is the same as the treatment group, and also the same retention and frequency. This study used the specifically made needle with a blunt tip, the Streitberger device, as the sham acupuncture. The needle does not penetrate the skin and retracts in the handle while the acupuncturist needles into the skin. | Other: Acupuncture<br>* Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function | Mini-Mental State Examination (MMSE) is used to assess include orientation, memory, calculation ability and attention, information registration, operational ability, language comprehension, spatial concepts. | The measurement is assessed before the first treatment, and recheck on 4th,8th week and 4 weeks after finishing the course of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration difficulty | The Stroop Color and Word Test (SCWT) was chosen to evaluate the changes in attention. | The measurement is assessed before the first treatment, and recheck on 4th,8th week and 4 weeks after finishing the course of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain fog