Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT06144320
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2023-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Acupuncture in Patients Post-Covid Brain Fog
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005222', 'term': 'Mental Fatigue'}], 'ancestors': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-11-21', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': 'Mini-Mental State Examination (MMSE) is used to assess include orientation, memory, calculation ability and attention, information registration, operational ability, language comprehension, spatial concepts.'}], 'secondaryOutcomes': [{'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.', 'description': 'The Stroop Color and Word Test (SCWT) was chosen to evaluate the changes in attention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain fog'], 'conditions': ['Brain Fog']}, 'referencesModule': {'references': [{'pmid': '36899952', 'type': 'BACKGROUND', '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.'}, {'pmid': '34223884', 'type': 'RESULT', '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.'}, {'pmid': '36351274', 'type': 'RESULT', '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.'}, {'pmid': '35768007', 'type': 'RESULT', '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.'}, {'pmid': '35773475', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nA randomized rater-blinded controlled study is proposed to see the efficacy of acupuncture for brain fog.", 'detailedDescription': "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.\n\nThe 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).\n\nA 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have been tested positive for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) or had serum antibody positivity more than 12 weeks before.\n2. Present cognitive impairment after been diagnosed as Covid-19\n3. Clinical Dementia Rating (CDR) score of 1\n4. Normal activities of daily living score (ADL)\n5. (Mini-Mental State Examination) MMSE score of 24-28\n6. Age of 18-65 years\n7. Signed informed consent\n\nExclusion Criteria:\n\n1. Diagnosed with any type of dementia.\n2. A history of acute or chronic cerebrovascular disease, encephalitis, Parkinson's disease, Leukoencephalopathy, and other central nervous system diseases\n3. A history of hypothyroidism, vitamin B12 deficiency, depression, syphilis, and other diseases that may affect cognitive decline.\n4. Severe hearing and visual impairment, inability to complete neuropsychological tests\n5. Impaired liver and kidney function and hematopoietic system disorders"}, 'identificationModule': {'nctId': 'NCT06144320', 'briefTitle': 'Efficacy of Acupuncture in Patients Post-Covid Brain Fog', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': '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).', 'orgStudyIdInfo': {'id': 'CMUH112-REC2-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': '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.', 'interventionNames': ['Other: Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo group', 'description': 'Practicing sham acupuncture on specific acupoints is the same as the treatment group, and also the same retention and frequency.\n\nThis 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.', 'interventionNames': ['Other: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Acupuncture is performed using acupuncture points recorded in traditional Chinese medicine books as helpful for cognitive impairment.', 'armGroupLabels': ['Placebo group', 'Treatment group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Chien Yu Huang', 'investigatorAffiliation': 'China Medical University Hospital'}}}}