Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 8:23 AM
Study NCT ID:
NCT05413460
Status:
UNKNOWN
Last Update Posted:
2022-12-06
First Post:
2022-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupoint Stimulation and Cranial Endovascular Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All participants are placed with electrodes at acupoints. The stimulator is put in an opaque box.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-02', 'studyFirstSubmitDate': '2022-05-25', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with major in-hospital postoperative complications', 'timeFrame': 'from end of surgery to discharge from hospital, in an average of 7 days', 'description': 'major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma'}], 'secondaryOutcomes': [{'measure': 'mortality by 30 days after surgery', 'timeFrame': 'from end of surgery to 30 days after surgery, in a total of 30 days'}, {'measure': 'mortality by 3 months after surgery', 'timeFrame': 'from end of surgery to 3 months after surgery, in a total of 3 months'}, {'measure': 'number of patients with major postoperative complications by 3 months after surgery', 'timeFrame': 'from end of surgery to 3 months after surgery, in a total of 3 months', 'description': 'major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma'}, {'measure': 'mortality by 6 months after surgery', 'timeFrame': 'from end of surgery to 6 months after surgery, in a total of 6 months'}, {'measure': 'number of patients with major postoperative complications by 6 months after surgery', 'timeFrame': 'from end of surgery to 6 months after surgery, in a total of 6 months', 'description': 'major complications include myocardial infarction, heart failure, respiratory failure, mechanical ventilation, cerebral infarction, delirium and coma'}, {'measure': 'duration of postoperative in-hospital stay', 'timeFrame': 'from end of surgery to discharge from hospital, in an average of 7 days'}, {'measure': 'serum interleukin-6 level at the end of the surgery', 'timeFrame': 'at end of the surgery'}, {'measure': 'serum tumor necrosis factor-α level at the end of the surgery', 'timeFrame': 'at end of the surgery'}, {'measure': 'episodes of hypotension during surgery', 'timeFrame': 'from start of surgery to end of surgery, in an average of 2 hours', 'description': 'hypotension is defined as mean arterial pressure decreased by more than 20% of the baseline and persisting more than 1 minute'}, {'measure': 'Score of Mini-mental State Examination at 1 day after surgery', 'timeFrame': 'at 24h after the end of surgery', 'description': 'A Mini-Mental State Examination (MMSE) is a set of 30 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE is with a maximal score of 30. A higher score means better cognitive function.'}, {'measure': 'Score of Mini-mental State Examination at 3 days after surgery', 'timeFrame': 'at 72h after the end of surgery', 'description': 'A Mini-Mental State Examination (MMSE) is a set of 30 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory). MMSE is with a maximal score of 30. A higher score means better cognitive function.'}, {'measure': 'visual analog scale of pain at 1 day after surgery', 'timeFrame': 'at 24h after the end of surgery', 'description': 'visual analogue scale is a scale of 10cm, 0 is for no pain, 10 is for pain that can not be tolerated. The participant is asked to mark the scale of their pain'}, {'measure': 'visual analog scale of pain at 3 days after surgery', 'timeFrame': 'at 72h after the end of surgery', 'description': 'visual analogue scale is a scale of 10cm, 0 is for no pain, 10 is for pain that can not be tolerated. The participant is asked to mark the scale of their pain'}, {'measure': 'Quality of recovery score at 3 days after surgery', 'timeFrame': 'at 72h after the end of surgery', 'description': 'Quality of recovery-40 is a questionnaire consisted of 40 questions about the recovery of the patient. Higher score means better recovery.'}, {'measure': "Rankin's score at 3 days after surgery", 'timeFrame': 'at 72h after the end of surgery', 'description': "Rankin's score consists of class of 6 levels and is used for evaluation of neurologic function. Higher score means worse outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcutaneous electrical acupoint stimulation', 'endovascular treatment'], 'conditions': ['Cerebral Aneurysm']}, 'referencesModule': {'references': [{'pmid': '35450928', 'type': 'BACKGROUND', 'citation': 'Dhillon PS, Butt W, Podlasek A, McConachie N, Lenthall R, Nair S, Malik L, Hewson DW, Bhogal P, Makalanda HLD, James MA, Dineen RA, England TJ. Association between anesthesia modality and clinical outcomes following endovascular stroke treatment in the extended time window. J Neurointerv Surg. 2023 May;15(5):478-482. doi: 10.1136/neurintsurg-2022-018846. Epub 2022 Apr 21.'}, {'pmid': '34806930', 'type': 'BACKGROUND', 'citation': 'Campbell D, Deng C, McBryde F, Billing R, Diprose WK, Short TG, Frampton C, Brew S, Barber PA; MASTERSTROKE Study Group. Protocol for the MAnagement of Systolic blood pressure during Thrombectomy by Endovascular Route for acute ischemic STROKE randomized clinical trial: The MASTERSTROKE trial. Int J Stroke. 2022 Aug;17(7):810-814. doi: 10.1177/17474930211059029. Epub 2021 Nov 22.'}, {'pmid': '34538090', 'type': 'BACKGROUND', 'citation': 'Samuels N, van de Graaf RA, van den Berg CAL, Uniken Venema SM, Bala K, van Doormaal PJ, van der Steen W, Witvoet E, Boiten J, den Hertog H, Schonewille WJ, Hofmeijer J, Schreuder F, Schreuder TAHCML, van der Worp HB, Roos YBWEM, Majoie CBLM, Burke JF, van Es ACGM, van der Lugt A, Roozenbeek B, Lingsma HF, Dippel DWJ; MR CLEAN Registry Investigators. Blood Pressure in the First 6 Hours Following Endovascular Treatment for Ischemic Stroke Is Associated With Outcome. Stroke. 2021 Nov;52(11):3514-3522. doi: 10.1161/STROKEAHA.120.033657. Epub 2021 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective randomized controlled trial, the subjects will be assigned to group transcutaneous electrical acupoint stimulation (TEAS) and group control (no intervention). The postoperative outcomes including NIHSS (National Institute of Health stroke scale) score, morbidity and mortality will be evaluated during hospital stay and by one year after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥18 years\n2. patients scheduled for cranial endovascular treatment\n\nExclusion Criteria:\n\n1. American Society of Anesthesiologists class Ⅲ or higher\n2. Hunt-Hess class Ⅲ or higher\n3. body mass index (BMI) \\< 18 kg/㎡ or \\> 30kg/㎡\n4. large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm\n5. posterior circulation infarction\n6. recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping\n7. severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure\n8. injury or infection of the skin around the acupoint area\n9. participate in other clinical researchers within 3 months\n10. history of neurological or psychiatric diseases\n11. patients with implanted electrophysiological device\n12. use of sedative or analgesics before surgery\n13. patients with difficulty in communication'}, 'identificationModule': {'nctId': 'NCT05413460', 'acronym': 'ASSET', 'briefTitle': 'Acupoint Stimulation and Cranial Endovascular Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Complications After Cranial Endovascular Treatment', 'orgStudyIdInfo': {'id': 'XJH-A-20200730'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'transcutaneous electrical acupoint stimulation', 'description': 'Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.', 'interventionNames': ['Device: transcutaneous electrical acupoint stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Electrodes are placed at acupoints and connected to the stimulator. But no stimulation is given during surgery.'}], 'interventions': [{'name': 'transcutaneous electrical acupoint stimulation', 'type': 'DEVICE', 'otherNames': ['TEAS'], 'description': 'Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.', 'armGroupLabels': ['transcutaneous electrical acupoint stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhihong Lu', 'role': 'CONTACT', 'email': 'deerlu23@163.com', 'phone': '13891975018'}], 'facility': 'Xijing hospital, Fourth military medical university', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Zhihong Lu', 'role': 'CONTACT', 'email': 'deerlu23@163.com', 'phone': '+8613891975018'}, {'name': 'Minjuan Zhang', 'role': 'CONTACT', 'email': '947391349@qq.com', 'phone': '8684775343'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhihong LU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}