Clinical trial NCT06144320: Efficacy of Acupuncture in Patients Post-Covid Brain Fog
Official title: 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).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Fog
Keywords: Brain fog
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: cognitive function
timeFrame: The measurement is assessed before the first treatment, and recheck on 4th,8th week and 4 weeks after finishing the course of treatment.
Secondary outcomes:
measure: Concentration difficulty
timeFrame: The measurement is assessed before the first treatment, and recheck on 4th,8th week and 4 weeks after finishing the course of treatment.
Other outcomes:
Locations:
Study officials:
References:
citation: Leng A, Shah M, Ahmad SA, Premraj L, Wildi K, Li Bassi G, Pardo CA, Choi A, Cho SM. Pathogenesis Underlying Neurological Manifestations of Long COVID Syndrome and Potential Therapeutics. Cells. 2023 Mar 6;12(5):816. doi: 10.3390/cells12050816.
citation: Seessle J, Waterboer T, Hippchen T, Simon J, Kirchner M, Lim A, Muller B, Merle U. Persistent Symptoms in Adult Patients 1 Year After Coronavirus Disease 2019 (COVID-19): A Prospective Cohort Study. Clin Infect Dis. 2022 Apr 9;74(7):1191-1198. doi: 10.1093/cid/ciab611.
citation: Venkataramani V, Winkler F. Cognitive Deficits in Long Covid-19. N Engl J Med. 2022 Nov 10;387(19):1813-1815. doi: 10.1056/NEJMcibr2210069. No abstract available.
citation: Kao J, Frankland PW. COVID fog demystified. Cell. 2022 Jul 7;185(14):2391-2393. doi: 10.1016/j.cell.2022.06.020. Epub 2022 Jun 15.
citation: Lempriere S. Inflammation links mild COVID-19 with long-term cognitive impairment. Nat Rev Neurol. 2022 Aug;18(8):453. doi: 10.1038/s41582-022-00694-x.