Back to resultsEffects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
Primary Purpose
Schizophrenia, Psychosis, Parkinsonism
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Rhythmic auditory stimulation (RAS) for schizophrenia patients
No RAS for schizophrenia patients
RAS for at-risk individuals
No RAS for at-risk individuals
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
For at-risk individuals:
The inclusion criteria for at-risk individuals are:
- 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);
- A score of or above 22 in the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) to ensure that they can understand instructions;
- A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory to ensure that they are right-handed.
- The age ≥ 13 years.
The inclusion criteria for healthy controls are:
- A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;
- A score of or above 22 in MoCA;
- A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;
- No first-degree family members having a diagnosis of mental illnesses.
- The age ≥ 13 years.
At-risk participants and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.
For schizophrenia patients:
The inclusion criteria for schizophrenia patients are:
- A diagnosis of schizophrenia without other psychiatric diseases;
- Having stable psychotic symptoms;
- A score of or above 22 in HK-MoCA;
- A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory.
- The age ≥ 18 years.
The inclusion criteria for healthy controls are:
- A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;
- A score of or above 22 in MoCA;
- A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;
- No first-degree family members having a diagnosis of mental illnesses.
- The age ≥ 18 years.
Patients and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.
Sites / Locations
- Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
schizophrenia- RAS
schizophrenia- no RAS
at risk- RAS
at risk- no RAS
Arm Description
Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of rhythmic auditory stimulation (RAS).
Schizophrenia patients in the control group will receive upper-limb training without the aid of RAS.
At-risk individuals in the experimental group will undergo upper-limb movement training with the aid of RAS.
At-risk individuals in the control group will receive upper-limb training without the aid of RAS.
Outcomes
Primary Outcome Measures
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04553835
Brief Title
Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
Official Title
Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr WANG Shumei
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychosis, Parkinsonism, Dyskinesias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
schizophrenia- RAS
Arm Type
Experimental
Arm Description
Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of rhythmic auditory stimulation (RAS).
Arm Title
schizophrenia- no RAS
Arm Type
Active Comparator
Arm Description
Schizophrenia patients in the control group will receive upper-limb training without the aid of RAS.
Arm Title
at risk- RAS
Arm Type
Experimental
Arm Description
At-risk individuals in the experimental group will undergo upper-limb movement training with the aid of RAS.
Arm Title
at risk- no RAS
Arm Type
Active Comparator
Arm Description
At-risk individuals in the control group will receive upper-limb training without the aid of RAS.
Intervention Type
Behavioral
Intervention Name(s)
Rhythmic auditory stimulation (RAS) for schizophrenia patients
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
No RAS for schizophrenia patients
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
RAS for at-risk individuals
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
No RAS for at-risk individuals
Intervention 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.
Primary Outcome Measure Information:
Title
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Description
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Time Frame
Within one week right before the 1st session of the intervention
Title
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Description
normalized movement time (representing severity of parkinsonism). Unit: second/mm
Time Frame
Within one week right after the last session of the intervention
Title
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Description
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Time Frame
Within one week right before the 1st session of the intervention
Title
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Description
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Time Frame
Within one week right after the last session of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For at-risk individuals:
The inclusion criteria for at-risk individuals are:
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);
A score of or above 22 in the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) to ensure that they can understand instructions;
A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory to ensure that they are right-handed.
The age ≥ 13 years.
The inclusion criteria for healthy controls are:
A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;
A score of or above 22 in MoCA;
A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;
No first-degree family members having a diagnosis of mental illnesses.
The age ≥ 13 years.
At-risk participants and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.
For schizophrenia patients:
The inclusion criteria for schizophrenia patients are:
A diagnosis of schizophrenia without other psychiatric diseases;
Having stable psychotic symptoms;
A score of or above 22 in HK-MoCA;
A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory.
The age ≥ 18 years.
The inclusion criteria for healthy controls are:
A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;
A score of or above 22 in MoCA;
A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;
No first-degree family members having a diagnosis of mental illnesses.
The age ≥ 18 years.
Patients and healthy controls will be excluded if they have any neurological / musculoskeletal dysfunction that may affect their upper-limb movements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Mei Wang, PhD
Phone
852-27664197
Email
shumei.wang@polyu.edu.hk
Facility Information:
Facility Name
Hong Kong Polytechnic University
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Mei Wang, PhD
Phone
852-27664197
Email
shumei.wang@polyu.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
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