Efficacy of Acupuncture in Patients Post-Covid Brain Fog
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).
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 21, 2023
CompletedFirst Posted
Study publicly available on registry
November 22, 2023
CompletedNovember 29, 2023
July 1, 2023
Same day
November 21, 2023
November 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Concentration difficulty
The measurement is assessed before the first treatment, and recheck on 4th,8th week and 4 weeks after finishing the course of treatment.
Study Arms (2)
Treatment group
EXPERIMENTALPracticing 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.
Placebo group
SHAM COMPARATORPracticing 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.
Interventions
Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
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.
PMID: 36899952BACKGROUNDSeessle 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.
PMID: 34223884RESULTVenkataramani 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.
PMID: 36351274RESULTKao 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.
PMID: 35768007RESULTLempriere 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.
PMID: 35773475RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
November 21, 2023
First Posted
November 22, 2023
Study Start
November 1, 2023
Primary Completion
November 1, 2023
Study Completion
November 1, 2023
Last Updated
November 29, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share