Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients

Schizophrenia Clinical Trial

Official title:

Effects of Rhythmic Auditory Stimulation on Movements in Individuals at Risk for Psychotic Onset and Schizophrenia Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04553835
• Other study ID #: HSEARS20200630002
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: The Hong Kong Polytechnic University
• Contact: Shu-Mei Wang, PhD
• Phone: 852-27664197
• Email: shumei.wang[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

For at-risk individuals:

The inclusion criteria for at-risk individuals are:

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. A score of or above 22 in the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) to ensure that they can understand instructions;

3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory to ensure that they are right-handed.

4. The age = 13 years.

The inclusion criteria for healthy controls are:

1. A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;

2. A score of or above 22 in MoCA;

3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;

4. No first-degree family members having a diagnosis of mental illnesses.

5. 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:

1. A diagnosis of schizophrenia without other psychiatric diseases;

2. Having stable psychotic symptoms;

3. A score of or above 22 in HK-MoCA;

4. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory.

5. The age = 18 years.

The inclusion criteria for healthy controls are:

1. A score below the cut-off score of CPQ-16, CAPE-C15, and SPQ-B;

2. A score of or above 22 in MoCA;

3. A score of or above 60 in the Chinese Version of Edinburgh Handedness Inventory;

4. No first-degree family members having a diagnosis of mental illnesses.

5. 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.

Related Conditions & MeSH terms

• Dyskinesias
• Parkinsonian Disorders
• Parkinsonism
• Psychosis
• Schizophrenia

Intervention

Behavioral:
• Rhythmic auditory stimulation (RAS) for schizophrenia patients
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 patients
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 individuals
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 individuals
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	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 parkinsonism). 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 parkinsonism). 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