Efficacy of Acupuncture in Patients Post-Covid Brain Fog

November 24, 2023 updated by: Chien Yu Huang, China Medical University Hospital

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).

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Acupuncture
Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.
Sham Comparator: 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.
Other: Acupuncture
Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: The measurement is assessed before the first treatment, and recheck on 4th,8th week and 4 weeks after finishing the course of treatment.
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
Time Frame: The measurement is assessed before the first treatment, and recheck on 4th,8th week and 4 weeks after finishing the course of treatment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH112-REC2-108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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