Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-05 @ 6:23 PM
Study NCT ID:
NCT06600932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of TMS Visual Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-15', 'studyFirstSubmitDate': '2024-09-15', 'studyFirstSubmitQcDate': '2024-09-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual quality', 'timeFrame': 'From enrollment to the end of treatment at 12 weeks', 'description': 'Include objective visual quality (contrast sensitivity) and subjective visual quality (visual function questionnaire score).'}], 'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks'}], 'secondaryOutcomes': [{'measure': 'Visual field', 'timeFrame': 'From enrollment to the end of treatment at 2 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract Surgery Experience']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) can improve the visual outcomes in patients after cataract surgery. The main question it aims to answer is:\n\n• Does TMS improve the visual outcome in patients after cataract surgery? Researchers will compare TMS to the sham-controlled treatment (exposure to recorded sounds of pulses without real magnetic stimulation) to see if TMS works to improve the visual outcomes of patients after cataract surgery.\n\nParticipants will\n\n* Undergo TMS treatment or a sham-controlled treatment for consecutive 5 days.\n* Visit the clinic once every 2 weeks for checkups and tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Post cataract surgery\n* Best-corrected visual acuity less than 0.1logMAR\n\nExclusion Criteria:\n\n* Diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment;\n* Diagnosed with significant opacity of refractive media that affects observation of visual function;\n* History of epileptic seizures;\n* Long term use of psychotropic drugs；\n* Metal implants in the body.'}, 'identificationModule': {'nctId': 'NCT06600932', 'briefTitle': 'Evaluation of TMS Visual Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai High Myopia Study Group'}, 'officialTitle': 'Effects of Transcranial Magnetic Stimulation on Visual Outcome in Patients After Cataract Surgery', 'orgStudyIdInfo': {'id': 'HMSG2024015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TMS', 'description': 'TMS treatment indicates a non-invasive procedure called transcranial magnetic simulation (TMS) on cortex. The treatment intensity is set as 80% of the threshold of each participant. The treatment will be conducted every day for consecutive 5 days.', 'interventionNames': ['Procedure: TMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'The sham group will be exposed to the recorded sounds of TMS pulses but without real magnetic stimulation.', 'interventionNames': ['Procedure: control group']}], 'interventions': [{'name': 'TMS', 'type': 'PROCEDURE', 'description': 'TMS treatment in this study indicates a non-invasive procedure called transcranial magnetic simulation (TMS) on visual cortex. The treatment intensity is set as 80% of the threshold of each participant. The treatment will be conducted every day for consecutive 5 days.', 'armGroupLabels': ['TMS']}, {'name': 'control group', 'type': 'PROCEDURE', 'description': 'The control treatment is a sham-controlled procedure, in which participants will be exposed to the recorded sounds of TMS pulses but without real magnetic stimulation.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200031', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Xiangjia Zhu', 'role': 'CONTACT', 'email': 'zhuxiangjia1982@126.com', 'phone': '0086+02164377134'}], 'facility': 'Eye and Ear, Nose Throat Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiangjia Zhu', 'role': 'CONTACT', 'email': 'zhuxiangjia1982@126.com', 'phone': '0086+02164377134'}], 'overallOfficials': [{'name': 'Xiangjia Zhu', 'role': 'STUDY_CHAIR', 'affiliation': 'Eye and ENT Hospital of Fudan University'}, {'name': 'Jiaqi Meng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye and ENT Hospital of Fudan University'}, {'name': 'Yinglei Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye and ENT Hospital of Fudan University'}, {'name': 'Yating Tang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye and ENT Hospital of Fudan University'}, {'name': 'Xin Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye and ENT Hospital of Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai High Myopia Study Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}