Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-21 @ 10:01 PM
Study NCT ID:
NCT04617366
Status:
UNKNOWN
Last Update Posted:
2022-02-23
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Individualized rTMS Based on fNIRS
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-11-01', 'lastUpdatePostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer motor function score of upper limb', 'timeFrame': '3 months', 'description': 'The score range is 0-66 points, the higher the score, the better the motor function of upper limb.'}], 'secondaryOutcomes': [{'measure': 'Barthel index', 'timeFrame': '3 months', 'description': 'The score range is 0-100 points, the higher the score, the better the activities of daily living.'}, {'measure': 'Lateralization index (LI)', 'timeFrame': '3 months', 'description': 'The LI score measured by fNIRS ranges from -1 to 1, with 1 indicating purely ipsilesional and -1 indicating purely contralesional activation.'}, {'measure': 'Brain functional connection network', 'timeFrame': '3 months', 'description': 'Using fNIRS to analyze the functional connection network between the motor areas of the bilateral cerebral hemispheres.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Rehabilitation', 'Repetitive Transcranial Magnetic Stimulation', 'Functional Near-infrared Spectroscopy']}, 'descriptionModule': {'briefSummary': 'Stroke patients do not respond well to the traditional repetitive transcranial magnetic stimulation (rTMS) strategy based on the competitive model. The studies found that the contralesional motion cortex has a compensatory effect on the realization of the motor function of the affected side-the compensatory model, and the degree of compensation will change as the function changes. The optimal neural regulation strategies under different models are opposite, so it is important to accurately evaluate which of the two models plays the leading role. And functional near-infrared spectroscopy (fNIRS) may accurately and quickly assess cortical function in order to determine the degree of participation of the contralesional motion cortex. We propose that the dynamic individualized strategy which adjust the rTMS parameters promptly based on the results of fNIRS will be better than the traditional stimulation strategy. This project will apply a blinded-assessment randomized controlled trial. The test group selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS. And the control group will always be given low-frequency rTMS to contralesional M1. The difference in the improvement of upper limb function between the two groups of patients was compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 40-79 years;\n* Patients with first-onset subcortical infarcts within1 to 3 weeks after onset;\n* TMS on the lesion side can induce motor evoked potential(MEP) of the abductor pollicis brevis muscle of the affected hand;\n* Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;\n* The patient or its authorized agent signs the informed consent form.\n\nExclusion Criteria:\n\n* Previous seizures;\n* Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset;\n* Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.'}, 'identificationModule': {'nctId': 'NCT04617366', 'briefTitle': 'Dynamic Individualized rTMS Based on fNIRS', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Effect of Dynamic Individualized rTMS Based on fNIRS on Upper Limb Function of Stroke Patients', 'orgStudyIdInfo': {'id': 'XJUFH-R-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized rTMS strategy', 'description': 'The individualized strategy will adjust the rTMS parameters promptly based on the results of fNIRS. This arm selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS.', 'interventionNames': ['Other: Individualized rTMS strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional rTMS strategy', 'description': 'The control group will always be given low-frequency rTMS to contralesional M1.', 'interventionNames': ['Other: Traditional rTMS strategy']}], 'interventions': [{'name': 'Individualized rTMS strategy', 'type': 'OTHER', 'description': 'It will adjust the rTMS parameters based on the results of fNIRS.', 'armGroupLabels': ['Individualized rTMS strategy']}, {'name': 'Traditional rTMS strategy', 'type': 'OTHER', 'description': 'The patients will always be given low-frequency rTMS to contralesional M1.', 'armGroupLabels': ['Traditional rTMS strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ziwen Yuan, MD.', 'role': 'CONTACT', 'email': 'yuanziwen@xjtufh.edu.cn', 'phone': '+8617502991129'}], 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Ziwen Yuan, MD.', 'role': 'CONTACT', 'email': 'yuanziwen@xjtufh.edu.cn', 'phone': '+8617502991129'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}