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

Sponsor
Dr WANG Shumei (Other)
Overall Status
Recruiting
CT.gov ID
NCT04929795
Collaborator
(none)
36
1
4
28.6
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Rhythmic auditory stimulation (RAS)
  • Behavioral: no RAS
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Music Beat on Motor Function in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
Actual Study Start Date :
Aug 11, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: at risk- RAS

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).

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.

Active Comparator: at risk- no RAS

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

Behavioral: 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.

Experimental: schizophrenia- RAS

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

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.

Active Comparator: schizophrenia- no RAS

Schizophrenia patients in the control group will receive upper-limb training without the aid of RAS.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right before the 1st session of the intervention]

    normalized movement time (representing severity of bradykinesia). Unit: second/mm

  2. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right after the last session of the intervention]

    normalized movement time (representing severity of bradykinesia). Unit: second/mm

  3. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right before the 1st session of the intervention]

    normalized number of movement units (representing severity of dyskinesia). Unit: units/mm

  4. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) [Within one week right after the last session of the intervention]

    normalized number of movement units (representing severity of dyskinesia). Unit: units/mm

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ST814, the Hong Kong Polytechnic University Kowloon Hong Kong

Sponsors and Collaborators

  • Dr WANG Shumei

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr WANG Shumei, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT04929795
Other Study ID Numbers:
  • HSEARS20210610001
First Posted:
Jun 18, 2021
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2021