Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 1:03 AM
Study NCT ID:
NCT05382260
Status:
UNKNOWN
Last Update Posted:
2023-01-23
First Post:
2022-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personal Music for 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2022-04-01', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional connectivity for Baseline EEG', 'timeFrame': 'After approximately 5 minutes baseline.', 'description': "EEG would record participants' cortical activity while they are keeping quiet with their eyes opened for 5 minutes, and parameters relative to functional connectivity which could be calculated from offline EEG data. The EEG data would be separated to five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz) and the functional connectivity would be calculated by each frequency bands."}, {'measure': 'Functional connectivity for relaxing music EEG', 'timeFrame': 'After approximately 5 minutes relaxing music.', 'description': "EEG would record participants' cortical activity while they are listening to relaxing music for approximately 5 minutes, and parameters relative to functional connectivity which could be calculated from offline EEG data. The EEG data would be separated to five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz) and the functional connectivity would be calculated by each frequency bands."}, {'measure': 'Functional connectivity for preferred music EEG', 'timeFrame': 'After approximately 5 minutes preferred music.', 'description': "EEG would record participants' cortical activity while they are listening to preferred music for approximately 5 minutes, and parameters relative to functional connectivity which could be calculated from offline EEG data. The EEG data would be separated to five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz) and the functional connectivity would be calculated by each frequency bands."}, {'measure': 'Functional connectivity for amplitude modulated sound EEG', 'timeFrame': 'After approximately 6 minutes amplitude modulated sound.', 'description': "EEG would record participants' cortical activity while they are listening to amplitude modulation sound for approximately 6 minutes, and parameters relative to functional connectivity which could be calculated from offline EEG data. The EEG data would be separated to five frequency bands: δ (1-4 Hz), θ (4-8 Hz), α (8-13 Hz), β (13-30 Hz), and γ (30-45 Hz) and the functional connectivity would be calculated by each frequency bands."}], 'secondaryOutcomes': [{'measure': 'Heart Rate Variability(HRV) for baseline', 'timeFrame': 'After approximately 5 minutes baseline.', 'description': "Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline."}, {'measure': 'Heart Rate Variability(HRV) for relaxing music', 'timeFrame': 'After approximately 5 minutes relaxing music.', 'description': "Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline."}, {'measure': 'Heart Rate Variability(HRV) for preferred music', 'timeFrame': 'After approximately 5 minutes preferred music.', 'description': "Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline."}, {'measure': 'Heart Rate Variability(HRV) for amplitude modulated sound', 'timeFrame': 'After approximately 6 minutes amplitude modulated sound.', 'description': "Another two electrodes would be placed upon the hands and record participants' heart rate. HRV would be analyzed offline."}, {'measure': 'The Music Therapy Assessment Tool for Awareness in Disorders of Consciousness(MATADOC)', 'timeFrame': 'After approximately 5 minutes preferred music.', 'description': 'A scale contains three sub-scale, such as Principal Subscale: Essential Categories(scoring from 0 to 17, with the higher scores, the better status), Musical parameter and behavioural response type(scoring from 13 to 26, with the higher scores, the better status), Clinical information to inform goal setting and clinical care. The music therapist would give score from watching the video after study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DOC', 'preferred music', 'functional connectivity'], 'conditions': ['Disorder of Consciousness']}, 'descriptionModule': {'briefSummary': 'Background: The evaluation and treatment of disorders of consciousness(DOC) is a challenging undertaking. Now many neuroimaging techniques were used to detect the level of consciousness and electroencephagram(EEG) was widely used because of its high temporal resolution. Music would be an effective for DOC, due to its highly arousal value. Preferred music was near to persons, so that it would excite more range of cortical and increase the functional connectivity between cortices.\n\nMethods: The exploratory study included 15 health controls and 30 DOC, with 15 minimally conscious state(MCS) and 15 vegetative state(VS). After 5 minutes baseline silence, they listened to relaxing music(RM), preferred music(PM) and amplitude modulated sound(AMS), with 5 minutes baseline silence in the end, meanwhile EEG recorded their cortical activity. Each music was appropriately 5 minutes and separated by 3 minutes washout.\n\nDiscussion: The study would verify the effect of preferred music to the functional connectivity of DOC. Music would excite the networks related to consciousness by cross-modal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. being DOC less than 1 year and more than 28 days;\n2. diagnosis of VS and MCS based on CRS-R;\n3. the auditory sub-scale of CRS-R scoring more than 0, or Auditory Brainstem Response showing no auditory injury at least one side;\n4. stopping using sedatives more than 24 hours prior to study;\n5. no history of neurological or psychiatric diseases.\n\nExclusion Criteria:\n\n1. Auditory Brainstem Response showing completely injured auditory pathway(disappeared wave Ⅴ);\n2. having epilepsy or EEG showing alpha-coma;\n3. widely range of injured scalp or bone.'}, 'identificationModule': {'nctId': 'NCT05382260', 'briefTitle': 'Personal Music for Disorders of Consciousness', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Can Personal Music Change the Functional Connectivity of Disorders of Consciousness', 'orgStudyIdInfo': {'id': 'L20220318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Disorders of consciousness(DOC)', 'description': 'The participants in this arm are disorders of consciousness, containing of vegetative state(VS) and minimally conscious state(MCS).', 'interventionNames': ['Other: Listening to music']}, {'type': 'OTHER', 'label': 'Health control', 'description': 'They are health people with normal hearing, acting as a control for DOC group.', 'interventionNames': ['Other: Listening to music']}], 'interventions': [{'name': 'Listening to music', 'type': 'OTHER', 'description': 'After 5 minutes baseline, participants would listen to three kinds of music with 3 minutes washout and another 5 minutes baseline in the end, while EEG would record their cortical activity. And the order of the three kinds of music is random.', 'armGroupLabels': ['Disorders of consciousness(DOC)', 'Health control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510280', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiuyou Xie, PhD', 'role': 'CONTACT', 'email': '764942251@qq.com', 'phone': '+86 139 0301 9604'}], 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qiuyi M Xiao, BSc', 'role': 'CONTACT', 'email': '2936404912@qq.com', 'phone': '+8618302083474'}, {'name': 'Qiuyou Xie, PhD', 'role': 'CONTACT', 'email': '764942251@qq.com', 'phone': '+8613903019604'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qiuyou Xie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Qiuyou Xie', 'investigatorAffiliation': 'Zhujiang Hospital'}}}}