SchizophreniaNCT04553835
Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
A study testing Rhythmic auditory stimulation (RAS) for schizophrenia patients, No RAS for schizophrenia patients and RAS for at-risk individuals in people with Schizophrenia and Psychosis, run by Dr WANG Shumei at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychosis, Parkinsonism
- What is being tested?
- Rhythmic auditory stimulation (RAS) for schizophrenia patients, No RAS for schizophrenia patients and RAS for at-risk individuals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Aug 2020to 31 Dec 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Polytechnic University
Kowloon
Shu-Mei Wang, PhD, 852-27664197, shumei.wang@polyu.edu.hk
About this study
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.
- Conditions
- Schizophrenia, Psychosis, Parkinsonism, Dyskinesias
- Being tested
- Rhythmic auditory stimulation (RAS) for schizophrenia patients, No RAS for schizophrenia patients, RAS for at-risk individuals, No RAS for at-risk individuals
- 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) for schizophrenia patientsBehavioural
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.
No RAS for schizophrenia patientsBehavioural
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.
RAS for at-risk individualsBehavioural
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.
No RAS for at-risk individualsBehavioural
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 |
|---|---|---|
| schizophrenia- RAS | Experimental | Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of rhythmic auditory stimulation (RAS). Receives: Behavioral: Rhythmic auditory stimulation (RAS) for schizophrenia patients |
| 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 for schizophrenia patients |
| at risk- RAS | Experimental | At-risk individuals in the experimental group will undergo upper-limb movement training with the aid of RAS. Receives: Behavioral: RAS for at-risk individuals |
| 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 for at-risk individuals |
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 parkinsonism). 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 parkinsonism). 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 posted17 Sep 2020
- Study start31 Aug 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (estimated)
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
- NCT04553835
- Sponsor's protocol ID
- HSEARS20200630002
- Status last verified
- May 2022
- First submitted
- 12 Sep 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT04553835
- Acronym / sponsor ID
- HSEARS20200630002
- Conditions
- Schizophrenia, Psychosis, Parkinsonism, Dyskinesias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr WANG ShumeiUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Sep 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| schizophrenia- RAS | Experimental | Behavioral: Rhythmic auditory stimulation (RAS) for schizophrenia patientsSchizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of rhythmic auditory stimulation (RAS). |
| schizophrenia- no RAS | Active comparator | Behavioral: No RAS for schizophrenia patientsSchizophrenia patients in the control group will receive upper-limb training without the aid of RAS. |
| at risk- RAS | Experimental | Behavioral: RAS for at-risk individualsAt-risk individuals in the experimental group will undergo upper-limb movement training with the aid of RAS. |
| at risk- no RAS | Active comparator | Behavioral: No RAS for at-risk individualsAt-risk individuals in the control group will receive upper-limb training without the aid of RAS. |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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) for schizophrenia patientsA 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. | Behavioural | schizophrenia- RAS |
| No RAS for schizophrenia patientsThe 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 | schizophrenia- no RAS |
| RAS for at-risk individualsA 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. | Behavioural | at risk- RAS |
| No RAS for at-risk individualsThe 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 |
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 parkinsonism). 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 parkinsonism). 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- 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.
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) for schizophrenia patients, No RAS for schizophrenia patients and RAS for at-risk individuals 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?
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: status not confirmed, as of the sponsor's last update on 23 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Mei Wang, PhD (852-27664197, shumei.wang@polyu.edu.hk), or a site near the patient. 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?
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 23 May 2022.