Brain FogNCT06144320
Efficacy of Acupuncture in Patients Post-Covid Brain Fog
A study testing Acupuncture in people with Brain Fog, run by China Medical University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Fog
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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).
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.
Read the 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.
- Conditions
- Brain Fog
- Being tested
- Acupuncture
- Keywords
- Brain fog
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Other: Acupuncture |
| Placebo group | Sham comparator | 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 Stroop Color and Word Test (SCWT) was chosen to evaluate the changes in attention.
Measured: The measurement is assessed before the first treatment, and recheck on 4th,8th week and 4 weeks after finishing the course of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Brain FogStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien Yu Huang, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144320
- Sponsor's protocol ID
- CMUH112-REC2-108
- Status last verified
- Jul 2023
- First submitted
- 21 Nov 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36899952Seessle 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.
PubMed 34223884Venkataramani 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.
PubMed 36351274Kao 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.
PubMed 35768007Lempriere 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.
PubMed 35773475
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06144320
- Acronym / sponsor ID
- CMUH112-REC2-108
- Conditions
- Brain Fog
- Keywords
- Brain fog
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: AcupuncturePracticing 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 comparator | Other: AcupuncturePracticing 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment. | Other | Placebo group, Treatment group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 36899952Leng 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.
- Results publication: PubMed 34223884Seessle 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.
- Results publication: PubMed 36351274Venkataramani 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.
- Results publication: PubMed 35768007Kao 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.
- Results publication: PubMed 35773475Lempriere 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Brain Fog, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144320, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.