Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-03 @ 4:17 AM
Study NCT ID:
NCT03099460
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Ocular Electroacupuncture on Abducens Nerve Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020434', 'term': 'Abducens Nerve Diseases'}, {'id': 'D004172', 'term': 'Diplopia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}], 'ancestors': [{'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Ocular Motility Rating Score at 6 Weeks', 'timeFrame': '6 week', 'description': 'The patient will receive grading of eyeball outward moving ability by investigator. The changes of rating score from baseline will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Angle of diplopia deviation', 'timeFrame': '6 week', 'description': 'Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically.'}, {'measure': 'Eyeball movement distance', 'timeFrame': '6 week', 'description': 'The distances of eyeball movement in outward direction will be measured. The differences between affected and healthy eye will be calculated.'}, {'measure': 'The quality of life questionnaire for ocular motor nerve palsy', 'timeFrame': '6 week', 'description': 'The patients will finish a questionnaire to evaluate their physical and psychological status during this trial.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electroacupuncture', 'abducens nerve palsy', 'eyeball movement', 'diplopia', 'ocular motility disorder'], 'conditions': ['Abducens Nerve Paralysis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to testify the efficacy of treating abducens nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.', 'detailedDescription': 'The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for abducens nerve palsy (ANP), through treating ANP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by abducens nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Criteria: Inclusion criteria;\n\n1. patient with confirmed diagnosis of abducens nerve palsy made by neurologist or ophthalmologist;\n2. patient in stable condition after treatment for primary disease;\n3. age between 18 to 80 years old without gender limitation;\n4. haven't received acupuncture intervention for ANP before;\n5. patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.\n\nExclusion criteria:\n\n1. those with other diagnosed medical conditions known to contribute to ANP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;\n2. those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;\n3. those with serious medical conditions that might limit their participation;\n4. those with eye or other location with serious infections;\n5. women who had a positive pregnancy test or who were planning to become pregnant during the study period;\n6. those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;\n7. who had participate in other clinical trials, which may affect the results."}, 'identificationModule': {'nctId': 'NCT03099460', 'briefTitle': 'Effects of Ocular Electroacupuncture on Abducens Nerve Palsy', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'A Randomized Trial of Ocular Electroacupuncture for Abducens Nerve Palsy', 'orgStudyIdInfo': {'id': '2017031601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ocular electroacupuncture', 'description': 'Patients will receive electroacupuncture for 40 mins with certain parameter at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by abducens nerve.', 'interventionNames': ['Other: ocular electroacupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'ocular acupuncture', 'description': 'Patients will receive acupuncture for 40 mins at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by abducens nerve.', 'interventionNames': ['Other: ocular acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham acupuncture', 'description': 'Patients will receive sham acupuncture for 40 mins at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by abducens nerve. When the care provider performed operating acupuncture, the needles of sham acupuncture set will not be inserted into the skin of patient.', 'interventionNames': ['Other: sham acupuncture']}], 'interventions': [{'name': 'ocular electroacupuncture', 'type': 'OTHER', 'description': "During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm. The electropuncture apparatus is used, each group of electrodes are distinguished with different colors of wires to generate current stimulations of current 1.0\\~1.5 milliampere (mA), voltage 9 volt(V), frequency 1.5 hertz (Hz), and duration of 40 minutes.", 'armGroupLabels': ['ocular electroacupuncture']}, {'name': 'ocular acupuncture', 'type': 'OTHER', 'description': "During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm.The duration of intervention is 40 minutes.", 'armGroupLabels': ['ocular acupuncture']}, {'name': 'sham acupuncture', 'type': 'OTHER', 'description': "During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm sham needle set is stick onto insertion area without piercing into the skin. The duration of intervention is 40 minutes.", 'armGroupLabels': ['sham acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lingyun Zhou, PhD', 'role': 'CONTACT', 'email': 'no1zhly@163.com', 'phone': '+86 13351113936'}, {'name': 'Tiejuan Liu, PhD', 'role': 'CONTACT', 'email': 'ltj850722@126.com', 'phone': '+86 13946062207'}], 'facility': 'The first affiliated hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'LingYun Zhou, PhD', 'role': 'CONTACT', 'email': 'no1zhly@163.com', 'phone': '+86 13351113936'}, {'name': 'TieJuan Liu, PhD', 'role': 'CONTACT', 'email': 'ltj850722@126.com', 'phone': '+86 13946062207'}], 'overallOfficials': [{'name': 'Lingyun Zhou, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Harbin Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}