Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
Study NCT ID:
NCT06822192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-01-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Temporally Interfering in Patients with Disorders of Consciousness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRS-R (Coma Recovery Scale-revised)', 'timeFrame': 'One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus', 'description': 'The CRS-R scale, with scores ranging from 0 to 23, can help to distinguish unresponsive arousal syndrome from micro-conscious states.'}, {'measure': 'Adverse reactions', 'timeFrame': 'One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus', 'description': 'Any adverse events related to the study'}], 'secondaryOutcomes': [{'measure': 'EEG', 'timeFrame': 'One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus', 'description': 'phase-locked values, α, β and other EEG power'}, {'measure': 'fNIRS（functional near-infrared spectroscopy）', 'timeFrame': 'One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus', 'description': 'functional connectivity'}, {'measure': 'GOS-E（Glasgow Outcome Scale - Extended）', 'timeFrame': '2 weeks, 1 month, and 3 months after the end of stimulation', 'description': 'The outcome of patients was divided into 8 grades by GOS-E, and the higher the grade, the better the prognosis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Disorders of Consciousness']}, 'referencesModule': {'references': [{'pmid': '37780965', 'type': 'BACKGROUND', 'citation': 'Zhu Z, Yin L. A mini-review: recent advancements in temporal interference stimulation in modulating brain function and behavior. Front Hum Neurosci. 2023 Sep 14;17:1266753. doi: 10.3389/fnhum.2023.1266753. eCollection 2023.'}, {'pmid': '39133053', 'type': 'BACKGROUND', 'citation': "Yang C, Xu Y, Feng X, Wang B, Du Y, Wang K, Lu J, Huang L, Qian Z, Wang Z, Chen N, Zhou J, Zhang C, Liu Y. Transcranial Temporal Interference Stimulation of the Right Globus Pallidus in Parkinson's Disease. Mov Disord. 2025 Jun;40(6):1061-1069. doi: 10.1002/mds.29967. Epub 2024 Aug 12."}]}, 'descriptionModule': {'briefSummary': 'This project will help the patient recover consciousness by giving TI (temporally interfering) treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nIn accordance with the international diagnostic criteria for MCS formulated by Giacino in 2002 or the diagnostic criteria for UWS proposed by Laureys in 2010; Patients with disease duration ≥28 days and unconscious improvement tendency in the past one month; No use of any sedative drugs or antiepileptic drugs (sodium or calcium channel blockers) in the past 1 month; stable vital signs; No obvious brain edema, hydrocephalus, and severe brain atrophy; Age from 18 to 70 years old; Informed consent was obtained from the patients' family members.\n\nExclusion Criteria:\n\nPrevious history of neurological or psychiatric disorders; Previous history of traumatic brain injury; History of cancer; Taking sedative drugs or antiepileptic drugs in the past 1 month; Unstable vital signs; Skull defect; The patients' family members did not sign the informed consent."}, 'identificationModule': {'nctId': 'NCT06822192', 'briefTitle': 'The Temporally Interfering in Patients with Disorders of Consciousness', 'organization': {'class': 'OTHER', 'fullName': "Zhejiang Provincial People's Hospital"}, 'officialTitle': 'The Efficacy and Safety of Temporally Interfering in Patients with Disorders of Consciousness', 'orgStudyIdInfo': {'id': 'TI-DOC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TI', 'interventionNames': ['Device: temporally interfering electrical stimulation']}], 'interventions': [{'name': 'temporally interfering electrical stimulation', 'type': 'DEVICE', 'description': 'temporally interfering electrical stimulation', 'armGroupLabels': ['TI']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Li Zhang', 'role': 'CONTACT', 'email': 'zhangli0407@zju.edu.cn', 'phone': '+86-13732274598'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Li Zhang, MD', 'investigatorAffiliation': "Zhejiang Provincial People's Hospital"}}}}