Efficacy of Acupuncture in Patients Post-Covid Brain Fog

NCT ID: NCT06144320

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2023-11-30

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.

Conditions

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Brain Fog

Keywords

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Brain fog

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.

Placebo group

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.

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type OTHER

Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.

Interventions

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Acupuncture

Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chien Yu Huang

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 36899952 (View on PubMed)

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.

Reference Type RESULT
PMID: 34223884 (View on PubMed)

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.

Reference Type RESULT
PMID: 36351274 (View on PubMed)

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.

Reference Type RESULT
PMID: 35768007 (View on PubMed)

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.

Reference Type RESULT
PMID: 35773475 (View on PubMed)

Other Identifiers

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CMUH112-REC2-108

Identifier Type: -

Identifier Source: org_study_id