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Effects of Music Beat on Motor Function 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)
no RAS
Sponsored by
Dr WANG Shumei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ST814, the 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

at risk- RAS

at risk- no RAS

schizophrenia- RAS

schizophrenia- no RAS

Arm 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).

At-risk individuals in the control group will receive upper-limb training without the aid of RAS.

Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of RAS.

Schizophrenia patients 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 bradykinesia). 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 bradykinesia). 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

First Posted
June 10, 2021
Last Updated
February 27, 2023
Sponsor
Dr WANG Shumei
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1. Study Identification

Unique Protocol Identification Number
NCT04929795
Brief Title
Effects of Music Beat on Motor Function in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
Official Title
Effects of Music Beat on Motor Function in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (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 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.

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
36 (Anticipated)

8. Arms, Groups, and Interventions

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 music beat serving as a type of rhythmic auditory stimulation (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.
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 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.
Intervention Type
Behavioral
Intervention Name(s)
Rhythmic auditory stimulation (RAS)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
no RAS
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 bradykinesia). 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 bradykinesia). 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
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For at-risk participants: Inclusion criteria: 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); the age between 15-24 years; score > 60 in The Chinese version of Edinburgh Handedness Inventory (CH-EBI) to ensure right handedness; and 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: psychiatric diagnosis by self-report; cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements; taking psychiatric medications; substance abuse; and being pregnant. For schizophrenia participants: Inclusion criteria: a diagnosis of schizophrenia without other psychiatric diseases; the age ≥ 18 years; score > 60 in CH-EBI to ensure right handedness; and score ≥ 22 in HK-MoCA to ensure no serious cognitive deficits so that they can understand instructions. Exclusion criteria: cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements; substance abuse; and being pregnant.
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
ST814, the 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

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Effects of Music Beat on Motor Function in Individuals at Risk for Psychotic Onset and Schizophrenia Patients

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