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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04929795
Other study ID # HSEARS20210610001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 11, 2021
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source The Hong Kong Polytechnic University
Contact Shu-Mei Wang, PhD
Phone 852-27664197
Email shumei.wang@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility For at-risk participants: Inclusion criteria: 1. 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); 2. the age between 15-24 years; 3. score > 60 in The Chinese version of Edinburgh Handedness Inventory (CH-EBI) to ensure right handedness; and 4. score = 22 in Montreal Cognitive Assessment Hong Kong Version (HK-MoCA) to ensure no serious cognitive deficits so that they can understand instructions. Exclusion criteria: 1. psychiatric diagnosis by self-report; 2. cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements; 3. taking psychiatric medications; 4. substance abuse; and 5. being pregnant. For schizophrenia participants: Inclusion criteria: 1. a diagnosis of schizophrenia without other psychiatric diseases; 2. the age = 18 years; 3. score > 60 in CH-EBI to ensure right handedness; and 4. score = 22 in HK-MoCA to ensure no serious cognitive deficits so that they can understand instructions. Exclusion criteria: 1. cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements; 2. substance abuse; and 3. being pregnant.

Study Design


Intervention

Behavioral:
Rhythmic auditory stimulation (RAS)
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.
no RAS
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.

Locations

Country Name City State
Hong Kong ST814, the Hong Kong Polytechnic University Kowloon

Sponsors (1)

Lead Sponsor Collaborator
Dr WANG Shumei

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) normalized movement time (representing severity of bradykinesia). Unit: second/mm Within one week right before the 1st session of the intervention
Primary Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) normalized movement time (representing severity of bradykinesia). Unit: second/mm Within one week right after the last session of the intervention
Primary 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 Within one week right before the 1st session of the intervention
Primary 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 Within one week right after the last session of the intervention
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