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

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 Overview

• Status: Recruiting
• Conditions: Schizophrenia; Dyskinesias; Parkinsonism; Psychosis
• Intervention / Treatment: Behavioral: Rhythmic auditory stimulation (RAS) for schizophrenia patients; Behavioral: No RAS for schizophrenia patients; Behavioral: RAS for at-risk individuals; Behavioral: No RAS for at-risk individuals

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Recruiting
    • Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: schizophrenia- RAS; Schizophrenia patients in the experimental group will undergo upper-limb movement training with the aid of rhythmic auditory stimulation (RAS).	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.
ACTIVE_COMPARATOR: schizophrenia- no RAS; Schizophrenia patients in the control group will receive upper-limb training without the aid of RAS.	Behavioral: 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.
EXPERIMENTAL: at risk- RAS; At-risk individuals in the experimental group will undergo upper-limb movement training with the aid of RAS.	Behavioral: 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Dr WANG Shumei

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: September 12, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (ACTUAL): September 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Basal Ganglia Diseases; Movement Disorders; Schizophrenia; Dyskinesias; Parkinsonian Disorders
• Other Study ID Numbers: HSEARS20200630002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No