Effects of RAS in SZ

NCT ID: NCT07086040

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2028-07-31

Brief Summary

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The two main groups of medicated patients with schizophrenia (SZ) are those receiving second-generation antipsychotics and those receiving first-generation antipsychotics. The purpose of this research project is to target each patient group to examine effects of rhythmic auditory stimulation (RAS) on upper-limb movements in medicated SZ patients in a 6-month follow-up period.

The main questions of this project are:

1. Does RAS reduce severity of upper-limb bradykinesia (slow movements) and dyskinesia (repetitive and involuntary movements) after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving second-generation antipsychotics? and
2. Does RAS reduce severity of upper-limb bradykinesia and dyskinesia after intervention, at 3-month follow-up and 6-month follow-up in SZ patients receiving first-generation antipsychotics?

Researchers will compare upper-limb movement training with the aid of RAS to upper-limb movement training without the aid of RAS to see if RAS works to improve upper-limb movements in SZ patients. Participants will:

1. Undergo an interview and movement tests and fill out questionnaires before and after the movement training program and at 3-month follow-up and 6-month follow-up; and
2. Receive movement training for 40 minutes per session for a total of 21 sessions.

Detailed Description

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Conditions

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Schizophrenia and Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SZ patients receiving second-generation antipsychotics + RAS

SZ patients receiving second-generation antipsychotics: Provision of upper-limb movement training with the aid of RAS

Group Type EXPERIMENTAL

RAS incorporated in upper-limb movement training

Intervention Type BEHAVIORAL

RAS will be metronome beat sound with different tempi and will be incorporated in upper-limb movement training, which will last for 40 minutes per session for a total of 21 sessions.

SZ patients receiving second-generation antipsychotics + no RAS

SZ patients receiving second-generation antipsychotics: Provision of upper-limb movement training without the aid of RAS

Group Type ACTIVE_COMPARATOR

Upper-limb movement training

Intervention Type BEHAVIORAL

Upper-limb movement training will last for 40 minutes per session for a total of 21 sessions.

SZ patients receiving first-generation antipsychotics + RAS

SZ patients receiving first-generation antipsychotics: Provision of upper-limb movement training with the aid of RAS

Group Type EXPERIMENTAL

RAS incorporated in upper-limb movement training

Intervention Type BEHAVIORAL

RAS will be metronome beat sound with different tempi and will be incorporated in upper-limb movement training, which will last for 40 minutes per session for a total of 21 sessions.

SZ patients receiving first-generation antipsychotics + no RAS

SZ patients receiving first-generation antipsychotics: Provision of upper-limb movement training without the aid of RAS

Group Type ACTIVE_COMPARATOR

Upper-limb movement training

Intervention Type BEHAVIORAL

Upper-limb movement training will last for 40 minutes per session for a total of 21 sessions.

Interventions

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RAS incorporated in upper-limb movement training

RAS will be metronome beat sound with different tempi and will be incorporated in upper-limb movement training, which will last for 40 minutes per session for a total of 21 sessions.

Intervention Type BEHAVIORAL

Upper-limb movement training

Upper-limb movement training will last for 40 minutes per session for a total of 21 sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of schizophrenia or schizoaffective disorder
* Between 18 to 60 years old
* Keeping the same antipsychotics and the same dosage at least 4 weeks right before joining the study
* A Edinburgh Handedness Inventory score of \> 60
* A Montreal Cognitive Assessment score of ≥ 24


* Between 18 to 60 years old
* A Edinburgh Handedness Inventory score of \> 60
* A Montreal Cognitive Assessment score of ≥ 24

Exclusion Criteria

* Substance abuse or drug abuse
* Neurological diseases or medical conditions that affect upper-limb movements and hearing
* Other psychiatric diagnoses in addition to a diagnosis of schizophrenia or schizoaffective disorder

\[For healthy participants\]


* Substance abuse or drug abuse
* Neurological diseases or medical conditions that affect upper-limb movements and hearing
* Psychiatric diagnoses
* Taking psychotropic medications
* Presence of first-degree relatives or siblings with diagnoses of psychiatric diseases.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shu-Mei Wang

OTHER

Sponsor Role lead

Responsible Party

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Shu-Mei Wang

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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National Taipei University of Nursing and Health Sciences

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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RAS in SZ

Identifier Type: -

Identifier Source: org_study_id

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