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

NCT04553835 | Unknown

• 1 other identifier: HSEARS20200630002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Psychosis; Parkinsonism; Dyskinesias

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

schizophrenia- RAS

EXPERIMENTAL

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

schizophrenia- no RAS

ACTIVE COMPARATOR

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

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.

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.

Behavioral: No RAS for at-risk individuals

Interventions

Rhythmic auditory stimulation (RAS) for schizophrenia patients BEHAVIORAL

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.

schizophrenia- RAS

No RAS for schizophrenia patients BEHAVIORAL

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.

schizophrenia- no RAS

RAS for at-risk individuals BEHAVIORAL

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.

at risk- RAS

No RAS for at-risk individuals BEHAVIORAL

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.

at risk- no RAS

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• 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.

Sponsors & Collaborators

• Dr WANG Shumei: lead

Study Sites (1)

Hong Kong Polytechnic University

Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Parkinsonian Disorders; Dyskinesias

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shu-Mei Wang, PhD

CONTACT

852-27664197; shumei.wang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: September 17, 2020
• Study Start: August 31, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)