Efficacy of Acupuncture in Patients Post-Covid Brain Fog

China Medical University

Status: Not yet enrolling

Conditions: Brain Fog

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06144320

CMUH112-REC2-108

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have been tested positive for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) or had serum antibody positivity more than 12 weeks before.
2. Present cognitive impairment after been diagnosed as Covid-19
3. Clinical Dementia Rating (CDR) score of 1
4. Normal activities of daily living score (ADL)
5. (Mini-Mental State Examination) MMSE score of 24-28
6. Age of 18-65 years
7. Signed informed consent

Exclusion criteria

1. Diagnosed with any type of dementia.
2. A history of acute or chronic cerebrovascular disease, encephalitis, Parkinson's disease, Leukoencephalopathy, and other central nervous system diseases
3. A history of hypothyroidism, vitamin B12 deficiency, depression, syphilis, and other diseases that may affect cognitive decline.
4. Severe hearing and visual impairment, inability to complete neuropsychological tests
5. Impaired liver and kidney function and hematopoietic system disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Treatment group

Experimental group

Description:

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.

Treatment:

Other: Acupuncture

Placebo group

Sham Comparator group

Description:

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.

Treatment:

Other: Acupuncture