Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-31 @ 2:35 AM
Study NCT ID:
NCT04553835
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2020-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Rhythmic Auditory Stimulation on Movements 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': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2020-09-12', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, '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 parkinsonism). 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 parkinsonism). 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': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Psychosis', 'Parkinsonism', 'Dyskinesias']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to examine effects of movement training with the aid of rhythmic auditory stimulation (RAS) on reducing severity of dyskinesia and bradykinesia in at-risk individuals and schizophrenia patients. The investigators hypothesize that training with the aid of RAS reduced severity of bradykinesia and dyskinesia in at-risk individuals as well as in schizophrenia patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For at-risk individuals:\n\nThe inclusion criteria for at-risk individuals are:\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. A score of or above 22 in the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) to ensure that they can understand instructions;\n3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory to ensure that they are right-handed.\n4. The age ≥ 13 years.\n\nThe inclusion criteria for healthy controls are:\n\n1. A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;\n2. A score of or above 22 in MoCA;\n3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;\n4. No first-degree family members having a diagnosis of mental illnesses.\n5. The age ≥ 13 years.\n\nAt-risk participants and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.\n\nFor schizophrenia patients:\n\nThe inclusion criteria for schizophrenia patients are:\n\n1. A diagnosis of schizophrenia without other psychiatric diseases;\n2. Having stable psychotic symptoms;\n3. A score of or above 22 in HK-MoCA;\n4. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory.\n5. The age ≥ 18 years.\n\nThe inclusion criteria for healthy controls are:\n\n1. A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;\n2. A score of or above 22 in MoCA;\n3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;\n4. No first-degree family members having a diagnosis of mental illnesses.\n5. The age ≥ 18 years.\n\nPatients and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.'}, 'identificationModule': {'nctId': 'NCT04553835', 'briefTitle': 'Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients', 'orgStudyIdInfo': {'id': 'HSEARS20200630002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'schizophrenia- RAS', 'description': 'Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of rhythmic auditory stimulation (RAS).', 'interventionNames': ['Behavioral: Rhythmic auditory stimulation (RAS) for schizophrenia patients']}, {'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 for schizophrenia patients']}, {'type': 'EXPERIMENTAL', 'label': 'at risk- RAS', 'description': 'At-risk individuals in the experimental group will undergo upper-limb movement training with the aid of RAS.', 'interventionNames': ['Behavioral: RAS for at-risk individuals']}, {'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 for at-risk individuals']}], 'interventions': [{'name': 'Rhythmic auditory stimulation (RAS) for schizophrenia patients', 'type': 'BEHAVIORAL', 'description': 'A mobile application, "metronome beats" developed by Stonekick Limited, will be used to give RAS when the participant executes the movement. 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 (beats per minute). 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%. Schizophrenia patients in the experimental group will undergo upper limb movement training with the aid of RAS. The intervention protocol will last for 3 weeks on the weekday basis (a total of 15 sessions) with one session (40 minutes) per weekday.', 'armGroupLabels': ['schizophrenia- RAS']}, {'name': 'No RAS for schizophrenia patients', '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': ['schizophrenia- no RAS']}, {'name': 'RAS for at-risk individuals', 'type': 'BEHAVIORAL', 'description': 'A mobile application, "metronome beats" developed by Stonekick Limited, will be used to give RAS when the participant executes the movement. 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 (beats per minute). 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%. At-risk individuals in the experimental group will undergo upper limb movement training with the aid of RAS. The intervention protocol will last for 3 weeks on daily basis (a total of 21 sessions), with one training session (40 minutes) per day.', 'armGroupLabels': ['at risk- RAS']}, {'name': 'No RAS for at-risk individuals', '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']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Shu-Mei Wang, PhD', 'role': 'CONTACT', 'email': 'shumei.wang@polyu.edu.hk', 'phone': '852-27664197'}], 'facility': 'Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Shu-Mei Wang, PhD', 'role': 'CONTACT', 'email': 'shumei.wang@polyu.edu.hk', 'phone': '852-27664197'}]}, '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'}}}}