SchizophreniaNCT04929795
Effects of Music Beat on Motor Function in Individuals At Risk for Psychotic Onset and Schizophrenia Patients
A study testing Rhythmic auditory stimulation (RAS) and no RAS in people with Schizophrenia and Psychosis, run by Dr WANG Shumei at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Schizophrenia, Psychosis, Parkinsonism
- What is being tested?
- Rhythmic auditory stimulation (RAS) and no RAS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Aug 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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);
- an age of 13 years or above;
- 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.
- 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.
Who cannot join
- 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:
Show all 9Show fewer
- cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements;
- substance abuse; and
- being pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Schizophrenia, Psychosis, Parkinsonism, Dyskinesias
- Being tested
- Rhythmic auditory stimulation (RAS), no RAS
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Parkinsonian Disorders, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic auditory stimulation (RAS)Behavioural
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 RASBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| at risk- RAS | Experimental | 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). Receives: Behavioral: Rhythmic auditory stimulation (RAS) |
| at risk- no RAS | Active comparator | At-risk individuals in the control group will receive upper-limb training without the aid of RAS. Receives: Behavioral: no RAS |
| schizophrenia- RAS | Experimental | Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of RAS. Receives: Behavioral: Rhythmic auditory stimulation (RAS) |
| schizophrenia- no RAS | Active comparator | Schizophrenia patients in the control group will receive upper-limb training without the aid of RAS. Receives: Behavioral: no RAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within one week right before the 1st session of the intervention
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
Measured: Within one week right after the last session of the intervention
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
Measured: Within one week right before the 1st session of the intervention
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
Measured: Within one week right after the last session of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start11 Aug 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr WANG Shumei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr WANG Shumei, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929795
- Sponsor's protocol ID
- HSEARS20210610001
- Status last verified
- Nov 2024
- First submitted
- 10 Jun 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang SM, Chan HY, Chan CY, Fong LY, Chan WL, Wu KY, Yip LC, Wong WY, Ng CL, Fong KNK. Effects of Music Rhythm on Movement Abnormalities in People With Psychotic-Like Experiences: A Pilot Randomised Controlled Trial Using Motion Analysis. Early Interv Psychiatry. 2025 Nov;19(11):e70111. doi: 10.1111/eip.70111.
PubMed 41254481
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Beat on Motor Function in Individuals At Risk for Psychotic Onset and Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT04929795
- Acronym / sponsor ID
- HSEARS20210610001
- Conditions
- Schizophrenia, Psychosis, Parkinsonism, Dyskinesias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dr WANG ShumeiUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| at risk- RAS | Experimental | Behavioral: Rhythmic auditory stimulation (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). |
| at risk- no RAS | Active comparator | Behavioral: no RASAt-risk individuals in the control group will receive upper-limb training without the aid of RAS. |
| schizophrenia- RAS | Experimental | Behavioral: Rhythmic auditory stimulation (RAS)Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of RAS. |
| schizophrenia- no RAS | Active comparator | Behavioral: no RASSchizophrenia patients in the control group will receive upper-limb training without the aid of RAS. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
- an age of 13 years or above;
- 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.
- a diagnosis of schizophrenia without other psychiatric diseases;
Key exclusion criteria (9 listed)
- psychiatric diagnosis by self-report;
- cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements;
- taking psychiatric medications;
- substance abuse; and
- being pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | at risk- RAS, schizophrenia- RAS |
| no RASThe training protocol will be the same as that used in the experimental group except the lack of RAS during execution of the movement task. | Behavioural | at risk- no RAS, schizophrenia- no RAS |
Primary outcome
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)
Time frame: Within one week right before the 1st session of the intervention
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)
Time frame: Within one week right after the last session of the intervention
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)
Time frame: Within one week right before the 1st session of the intervention
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)
Time frame: Within one week right after the last session of the intervention
normalized number of movement units (representing severity of dyskinesia). Unit: units/mm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 41254481Wang SM, Chan HY, Chan CY, Fong LY, Chan WL, Wu KY, Yip LC, Wong WY, Ng CL, Fong KNK. Effects of Music Rhythm on Movement Abnormalities in People With Psychotic-Like Experiences: A Pilot Randomised Controlled Trial Using Motion Analysis. Early Interv Psychiatry. 2025 Nov;19(11):e70111. doi: 10.1111/eip.70111.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic auditory stimulation (RAS) and no RAS in people with Schizophrenia and Psychosis, run by Dr WANG Shumei at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK) (time frame: Within one week right before the 1st session of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.