Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-02 @ 6:55 AM
Study NCT ID:
NCT06313866
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2024-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012903', 'term': 'Smell'}], 'ancestors': [{'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2024-03-10', 'studyFirstSubmitQcDate': '2024-03-10', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MoCA', 'timeFrame': '0,4 weeks after the intervention, 8 weeks after the intervention', 'description': 'Montreal Cognitive Assessment Scale'}], 'secondaryOutcomes': [{'measure': 'MMSE', 'timeFrame': '0,4 weeks after the intervention,8 weeks after the intervention', 'description': 'Mini-Mental State Examination'}, {'measure': 'MBI', 'timeFrame': '0,4 weeks after the intervention,8 weeks after the intervention', 'description': 'Barthel index score'}, {'measure': 'TCD', 'timeFrame': '0,4 weeks after the intervention', 'description': 'Transcranial Doppler examination'}, {'measure': 'Near-infrared functional imaging of the brain', 'timeFrame': '0,4 weeks after the intervention', 'description': 'Near-infrared functional imaging of the brain'}, {'measure': 'Magnetic resonance scanning', 'timeFrame': '0,4 weeks after the intervention', 'description': 'Magnetic resonance scanning'}, {'measure': 'the State Trait Anxiety Inventory (STAI)', 'timeFrame': '0,4 weeks after the intervention', 'description': 'the State Trait Anxiety Inventory (STAI)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, electroacupuncture combined with olfactory therapy group, and sham group with 35 people in each group. After the end of the treatment, the clinical efficacy was evaluated.', 'detailedDescription': 'The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, and electroacupuncture combined with olfactory therapy group, and sham group with 35 people in each group. All patients were treated with conventional drugs and general supportive treatment, and on the basis of this, the electroacupuncture group was given electroacupuncture treatment at bilateral Fengchi and Gongxue, the smell suction therapy group was given the intervention of volatile oil nasal suction of Acorus calamus, and the electroacupuncture group combined with smell and suction therapy group was given electroacupuncture treatment at the same time as the electroacupuncture treatment of bilateral Fengchi and Gongxue. In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. After the 1 month innervation,the main efficacy indicators: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Barthel Index (MBI) score, and the secondary efficacy indicators: Transcranial Doppler (TCD), near-infrared functional brain imaging , magnetic resonance examination， the heart rate,blood pressure and the State Trait Anxiety Inventory （STAI）are collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Stroke as per the TCM definition, presenting symptoms include unilateral paresis or paralysis, sensory deficits, speech impairment, and hemianopsia. PSCI diagnosis involves clinically significant deficits in at least one cognitive domain and severe disruption of instrumental ADLs/ADLs.; (2) The scores on the MMSE scale must adhere to the following criteria: Less than 17 points for individuals with illiteracy, less than 20 points for those with primary school education, and less than 24 points for individuals with a middle school education or higher.; (3) Aged under 70 years; (4) No history of mental illness, clear consciousness, stable vital signs, and able to complete the scale assessment; (5) Within 6 months post-stroke, diagnosed as a patient in the recovery period of cerebral infarction (or cerebral hemorrhage) at admission; (6) Signed informed consent by the patient or their family.\n\nExclusion Criteria:\n\n* (1) Transient ischemic attack; (2) Subarachnoid hemorrhage; (3) History of severe liver or kidney diseases, mental illness, epilepsy, asthma, or obstructive pulmonary diseases; (4) Occurrence of cognitive impairment prior to stroke; (5) Severe communication barriers; (6) Substance abuse or heavy alcohol consumption; (7) Implanted cardiac pacemakers or other electronic devices.'}, 'identificationModule': {'nctId': 'NCT06313866', 'briefTitle': 'the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI', 'organization': {'class': 'OTHER', 'fullName': 'Hangzhou Medical College'}, 'officialTitle': 'the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in the Treatment of Cognitive Impairment After Stroke', 'orgStudyIdInfo': {'id': '2024ZL368'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Donepezil hydrochloride was administered at 5 mg once a day (nightly) for 30 days without adverse reactions and then increased to 10 mg once a day (nightly) for 4 weeks.'}, {'type': 'EXPERIMENTAL', 'label': 'Electronuchal acupuncture group treatment', 'description': 'Use the neck needle to take the Fengchi and Gongxue on both sides (1.5cm directly below Fengchi point).', 'interventionNames': ['Dietary Supplement: control', 'Other: Electronuchal acupuncture group treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Smell therapy group treatment', 'description': 'The volatile oil of Acorus calamus is packed in the sniffer. Smell at the sniffing end, breathe evenly, 5-10 minutes each time, 3-5 times a day, for a total of 4 weeks of treatment.', 'interventionNames': ['Dietary Supplement: control', 'Other: Smell therapy group treatment']}, {'type': 'EXPERIMENTAL', 'label': 'The combined treatment', 'description': 'The electro-neuchal acupuncture combined with sniffing and suction therapy group is treated with sniffing and suction therapy on the basis of electro-neuchal acupuncture treatment.', 'interventionNames': ['Dietary Supplement: control', 'Other: Electronuchal acupuncture combined with smell and inhalation therapy group treatment']}, {'type': 'OTHER', 'label': 'normal', 'description': 'The volatile oil of Acorus calamus is packed in the sniffer. Smell at the sniffing end, breathe evenly, 5-10 minutes each time, 3-5 times a day, for a total of 4 weeks of treatment.', 'interventionNames': ['Other: Smell therapy group treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.', 'interventionNames': ['Other: Sham stimulation']}], 'interventions': [{'name': 'control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Donepezil hydrochloride was administered at 5 mg once a day (nightly) for 30 days without adverse reactions and then increased to 10 mg once a day (nightly) for 4 weeks.', 'armGroupLabels': ['Electronuchal acupuncture group treatment', 'Smell therapy group treatment', 'The combined treatment']}, {'name': 'Electronuchal acupuncture group treatment', 'type': 'OTHER', 'description': 'Electronuchal acupuncture', 'armGroupLabels': ['Electronuchal acupuncture group treatment']}, {'name': 'Smell therapy group treatment', 'type': 'OTHER', 'description': 'nasal suction intervention with volatile oil of Acorus calamus', 'armGroupLabels': ['Smell therapy group treatment', 'normal']}, {'name': 'Electronuchal acupuncture combined with smell and inhalation therapy group treatment', 'type': 'OTHER', 'description': 'On the basis of electric nuchal acupuncture treatment, sniffing and inhalation therapy is given.', 'armGroupLabels': ['The combined treatment']}, {'name': 'Sham stimulation', 'type': 'OTHER', 'description': 'In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture.', 'armGroupLabels': ['Sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '311000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinyun Dr LI, Doctor', 'role': 'CONTACT', 'email': 'lxyjasmine2010@163.com', 'phone': '8618069783240'}], 'facility': "the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College.", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xinyun Dr LI, Doctor', 'role': 'CONTACT', 'email': 'lxyjasmine2010@163.com', 'phone': '8618069783240'}], 'overallOfficials': [{'name': 'Xinyun Li, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'hangzhou medical colleage'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}