Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-27 @ 9:13 PM
Study NCT ID:
NCT04929795
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2021-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Music Beat on Motor Function in Individuals At Risk for Psychotic Onset and Schizophrenia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D020820', 'term': 'Dyskinesias'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2021-06-10', 'studyFirstSubmitQcDate': '2021-06-10', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)', 'timeFrame': 'Within one week right before the 1st session of the intervention', 'description': 'normalized movement time (representing severity of bradykinesia). Unit: second/mm'}, {'measure': 'Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)', 'timeFrame': 'Within one week right after the last session of the intervention', 'description': 'normalized movement time (representing severity of bradykinesia). Unit: second/mm'}, {'measure': 'Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)', 'timeFrame': 'Within one week right before the 1st session of the intervention', 'description': 'normalized number of movement units (representing severity of dyskinesia). Unit: units/mm'}, {'measure': 'Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)', 'timeFrame': 'Within one week right after the last session of the intervention', 'description': 'normalized number of movement units (representing severity of dyskinesia). Unit: units/mm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Psychosis', 'Parkinsonism', 'Dyskinesias']}, 'referencesModule': {'references': [{'pmid': '41254481', 'type': 'DERIVED', 'citation': 'Wang SM, Chan HY, Chan CY, Fong LY, Chan WL, Wu KY, Yip LC, Wong WY, Ng CL, Fong KNK. Effects of Music Rhythm on Movement Abnormalities in People With Psychotic-Like Experiences: A Pilot Randomised Controlled Trial Using Motion Analysis. Early Interv Psychiatry. 2025 Nov;19(11):e70111. doi: 10.1111/eip.70111.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to investigate whether a 3-week training program involving music beat (serving as a type of rhythmic auditory stimulation) reduces the severity of bradykinesia and dyskinesia in at-risk individuals and schizophrenia patients. It is hypothesized that the program is effective in reducing the severity of bradykinesia and dyskinesia in at-risk individuals and schizophrenia patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For at-risk participants:\n\nInclusion criteria:\n\n1. A score of or above 9 in the Chinese version of the 16-item Prodromal Questionnaire (CPQ-16), or a score of or above 8.18 in the Chinese version of Community Assessment of Psychic Experiences with 15 items (CAPE-C15), or a score of or above 17 in Schizotypal Personality Questionnaire-Brief (SPQ-B);\n2. an age of 13 years or above;\n3. score \\> 60 in The Chinese version of Edinburgh Handedness Inventory (CH-EBI) to ensure right handedness; and\n4. score ≥ 22 in Montreal Cognitive Assessment Hong Kong Version (HK-MoCA) to ensure no serious cognitive deficits so that they can understand instructions.\n\nExclusion criteria:\n\n1. psychiatric diagnosis by self-report;\n2. cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements;\n3. taking psychiatric medications;\n4. substance abuse; and\n5. being pregnant.\n\nFor schizophrenia participants:\n\nInclusion criteria:\n\n1. a diagnosis of schizophrenia without other psychiatric diseases;\n2. the age ≥ 18 years;\n3. score \\> 60 in CH-EBI to ensure right handedness; and\n4. score ≥ 22 in HK-MoCA to ensure no serious cognitive deficits so that they can understand instructions.\n\nExclusion criteria:\n\n1. cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements;\n2. substance abuse; and\n3. being pregnant.'}, 'identificationModule': {'nctId': 'NCT04929795', 'briefTitle': 'Effects of Music Beat on Motor Function in Individuals At Risk for Psychotic Onset and Schizophrenia Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effects of Music Beat on Motor Function in Individuals At Risk for Psychotic Onset and Schizophrenia Patients', 'orgStudyIdInfo': {'id': 'HSEARS20210610001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'at risk- RAS', 'description': 'At-risk individuals in the experimental group will undergo upper-limb movement training with the aid of music beat serving as a type of rhythmic auditory stimulation (RAS).', 'interventionNames': ['Behavioral: Rhythmic auditory stimulation (RAS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'at risk- no RAS', 'description': 'At-risk individuals in the control group will receive upper-limb training without the aid of RAS.', 'interventionNames': ['Behavioral: no RAS']}, {'type': 'EXPERIMENTAL', 'label': 'schizophrenia- RAS', 'description': 'Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of RAS.', 'interventionNames': ['Behavioral: Rhythmic auditory stimulation (RAS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'schizophrenia- no RAS', 'description': 'Schizophrenia patients in the control group will receive upper-limb training without the aid of RAS.', 'interventionNames': ['Behavioral: no RAS']}], 'interventions': [{'name': 'Rhythmic auditory stimulation (RAS)', 'type': 'BEHAVIORAL', 'description': 'The song named \'Sign of The Times\' is played and recorded by the research personnel beforehand. The beat of the song will serve as RAS. The computer software "Audacity" will be used to adjust tempi of RAS. Before intervention, the participant is required to execute the movement task without the aid of RAS as quickly as possible for 30 seconds, so that we obtain his/her baseline movement tempo. For each 40-minute training session in the first training week, three RAS tempi will be provided for the first, second, and last 10 minutes with a five-minute break in between: normal (100% of the baseline tempo), quick (105% of the baseline tempo), and fast (110% of the baseline tempo). With each training week, the three RAS tempi will be increased by 5%. Participants in the experimental groups are required to use their right hand to pick up beads from source bowls to the target bowl when listening to the song. The 3-week intervention program will include 21 40-minute daily training sessions.', 'armGroupLabels': ['at risk- RAS', 'schizophrenia- RAS']}, {'name': 'no RAS', 'type': 'BEHAVIORAL', 'description': 'The training protocol will be the same as that used in the experimental group except the lack of RAS during execution of the movement task.', 'armGroupLabels': ['at risk- no RAS', 'schizophrenia- no RAS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'country': 'Hong Kong', 'facility': 'ST814, the Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr WANG Shumei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr WANG Shumei', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}