Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-04-04 @ 1:44 PM
Study NCT ID:
NCT06723769
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Repeated Transcranial Magnetic Stimulation Based on Near-infrared Imaging in Patients With Post-stroke Depression
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Scale (HAMD-17)', 'timeFrame': 'pre and post 4 weeks treatment', 'description': 'evaluate the degree of depression'}, {'measure': 'Functional near-infrared spectroscopy (fNIRS assessment)', 'timeFrame': 'pre and post 4 weeks treatment', 'description': 'measure brain function to determine the effect of rTMS on cerebral blood flow change'}], 'secondaryOutcomes': [{'measure': 'Hamilton Anxiety Scale(HAMA)', 'timeFrame': 'pre and post 4 weeks treatment', 'description': 'evaluate the degree of anxiety'}, {'measure': 'National Institutes of Health Stroke Scale(NIHSS)', 'timeFrame': 'pre and post 4 weeks treatment', 'description': 'evaluate the degree of neurological impairment'}, {'measure': 'Barthel Index(BI)', 'timeFrame': 'pre and post 4 weeks treatment', 'description': 'evaluate the degree of daily living ability'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fNIRS', 'LF-rTMS', 'DLPFC'], 'conditions': ['Stroke', 'Post-stroke Depression']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial to evaluate the efficacy and safety of Low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) in post-stroke depression (PSD), explore mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).', 'detailedDescription': 'To evaluate the efficacy and safety of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) for the right dorsolateral prefrontal cortex (DLPFC) in patients with post-stroke depression (PSD), and explore the possible neural mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).\n\nPatients were randomly assigned to the rTMS and control groups. the treatment effect was assessed by the Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), National Institutes of Health Stroke Scale (NIHSS), and Barthel Index (BI). Meanwhile, fNIRS was used to detect the changes of blood oxygen concentration in the frontal cortex.\n\nAfter treatment, the score of the HAMD scale in the rTMS group decreased more significantly than in the control group (P\\<0.05). The value of CH17 oxyhemoglobin (HBO) and the value of CH6 deoxyhemoglobin (HBR) were decreased after rTMS. The HbR of CH6 and CH8 decreased significantly, the HbR of CH12 and CH15 increased significantly (P\\<0.05). The HAMA, NIHSS and Barthel scores improved more significantly in the rTMS group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Hospitalized patients over 18 years of age; (2) Meet the stroke diagnostic criteria of the Fourth National Conference on Cerebrovascular Diseases and have been confirmed as ischemic or hemorrhagic stroke by head CT and MRI; (3) Symptoms of PSD such as low mood, loss of interest in daily life, insomnia, or poor appetite persist for more than 1 week and meet the inclusion criteria of the DSM-5; (4) Hamilton Depression Scale score-17 (HAMD) \\> 7; (5) Stable vital signs, willing to accept the treatment method of this study, and sign the informed consent for treatment.\n\nExclusion Criteria:\n\n* (1) Patients with a history of mental disorders and depression before stroke onset; (2) Patients with consciousness disorder, severe aphasia or comprehension and expression disorder after stroke; (3) Patients with serious cognitive impairment can not cooperate with the psychological evaluator; (4) Patients with metal implants in the skull; (5) People with cardiac pacemakers; (6) Previous head trauma, alcoholism, or family history of epilepsy and another risk of seizures; (7) psychotic symptoms such as agitation, speech and behavior disorder; (8) refuse to sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT06723769', 'acronym': 'PSD fNIRS rTMS', 'briefTitle': 'Efficacy of Repeated Transcranial Magnetic Stimulation Based on Near-infrared Imaging in Patients With Post-stroke Depression', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Efficacy and Safety of Low-frequency Repetitive Transcranial Magnetic Stimulation in Post-stroke Depression: a Randomized Controlled fNIRS Study', 'orgStudyIdInfo': {'id': '20241204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'conventional treatment', 'interventionNames': ['Other: conventional treatment']}, {'type': 'EXPERIMENTAL', 'label': 'rTMS group', 'description': 'The rTMS group was treated with LF-rTMS based on the conventional treatment.', 'interventionNames': ['Device: rTMS treatment']}], 'interventions': [{'name': 'rTMS treatment', 'type': 'DEVICE', 'description': 'Repetitive transcranial magnetic stimulation (rTMS) is a new physiotherapy technique for the treatment of PSD Compared to other strategies, it has the advantages of simple operation, non-invasive, painless, and safe. Studies have comprehensively shown that rTMS can effectively improve depressive symptoms in PSD patients', 'armGroupLabels': ['rTMS group']}, {'name': 'conventional treatment', 'type': 'OTHER', 'description': 'general treatment of stabilizing vital signs (such as antidepressants, stabilizing blood pressure, stabilizing blood sugar, etc. ) and conventional rehabilitation treatment (hemiplegic limb comprehensive training, swallowing speech training, cognitive perception training, etc. ).', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,, Chongqing, Chongqing 400010', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Dingqun Bai', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dingqun Bai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of rehabilitation Medicine', 'investigatorFullName': 'Dingqun Bai', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}